The following Material numbers may appear on any of the attached recalled/corrected units: Material #0376288, Description: Federarm 3kg, 3 polig (Swing); 0376289, Federarm 12-18kg, 5-polig Kamera eco; 0376290, Federarm TFT Stop AC 2000, 9-15kg; 0376291, Federarm TFT Stop AC 3000, 12-18kg; 0376292, Federarm TFT Stop Space bis 30kg; 0376293, Federarm 3-polig NRH; 0376294, Federarm 5-polig NRH; 0376295, Federarm 3-polig NRH gerader Abgang; 0376296, Federarm 5-polig NRH gerader Abgang; 0379528, FA AC3000, Stop 7-11KG; 0385719, FA AC 2000 NRH mobil 3p, 12-18kg NG; 1387323, Federarmsicherungssegment AC3000; 1387324, Federarmsicherungssegment AC2000; 1388338, Federarm 12-18 kg 3 polig, HEL2; 1388339, Federarm 12-18 kg 5 polig HEL2; 1388340, Federarm 12-18 kg 9 polig (HELION); 1408906, FA AC2 Stop max 11kg; 1471010, FA AC2000 3p, 12-18kg; 1471011, FA AC2000 Stop 12-18kg; 1471012, FA AC2000 NRH 3p, 12-18kg; 1471013, FA AC2000, 7p, 12-18kg; 1471014, FA AC2000 NRH 7p, 12-18kg; 1471015, FA AC3000 3p, 23-30kg; 1471016, FA AC2000 Stop 6-11kg; 1471017, FA AC2000 TruVidia 7p, 3,5-7kg; 1471018, FA AC2000 Stop 3,5-7kg; 1471351, FA AC3000 NRH 3p, 23-30kg; 1502084, FA AC2 NRH f¿r HEL2, 3POL.; 1504731, Federarm 9-POLIG NRH HEL2; 1507085, (R)FEDERARM AC2000; 1645860, FA AC 2000 NRH mobil 7p, 12-18kg NG; 1645861, FA AC 2000 NRH 7p, 12-18kg NG; 1649687, FA AC 2000 SlimLine STOP, 12-18kg; 1649872, FA AC 2000 SlimLine 3p, 12-18kg; 1649997, Deckenrohr 2f Slimline 1000; 1774143, Ausleger AC2000, 750mm, 3p; 1982310, FA AC2000 MAVIG Protegra2 6-11kg; 1982311, FA AC2000 MAVIG Protegra2 12-18kg; 1982312, FA AC2000 3p, 13,5-21kg; 1982313, FA AC2000 NRH 3p, 13,5-21kg; 4024211, Federarm AC2000; 4024212, FA AC2 Stop; 4024213, FA AC3; 4024214, FA AC3000 Stop, 12-18kg; 4024215, FA AC5000 Stop; 4024651, FA AC3000, 7p; 4024652, FA AC2 3K; 024848, Federarm AC3000 NRH; 4025574, FA AC3000 Stop 23-30 kg; 4025575, FA AC5000 Stop max 15 kg; 4025576, FA AC2 K TruVidia; 8800900, Federarm HELION L+ 12,5 kg 5-polig; 8800901, Federarm HELION M+ 12,5 kg 3-polig; 8800905, Federarm HEL L/L+, 11,4 kg 3-polig; 8800906, Federarm HELION M NRH; 8800907, Federarm FA 77 V 11,4 kg 3 polig; 8800908, Federarm FA 77 V 6,8 kg 3 polig; 8800909, Federarm f¿r L-Leuchte So-Version; 8800910, Federarm f¿r M-Leuchte So-Version; 8800911, Federarm FA 77 V 13 kg 3 polig; 8800915, Federarm FA 77 N 11,4 kg5 polig; 8800916, Federarm FA 77 N 6,8 kg 5 polig; 8800919, Federarm FA 77 N 13 kg 5 polig; 8800920, Federarm FA 77 N 8,9 kg 5 polig; 8800925, Federarm FA 77 N 11,4 kg 7 polig; 8800926, Federarm Helion M NRH 7-polig; 8800929, Federarm FA 77 N 13 kg 7 polig; 8800930, Federarm FA 77 N 8,9 kg 7 polig; 8801000, Federarm HELION M+ 8.3 kg 5-polig; 8801001, Federarm HELION M+ 8,3 kg 3-polig; 8801007, Federarm AC 2000, 9-15 kg O. Elektrik; 8801008, Federarm AC 2000, 7-12 kg 5 polig; 8801009, Federarm AC 2000, 12-18 kg 5 polig; 8801010, Federarm Acrobat 2000 12-18 kg; 8801011, Federarm; 8801012, Federarm AC 2000 7-15 kg 3 polig mit; 8801013, Federarm AC 2000, 9-15 kg 7 polig; 8801014, Federarm f¿r Helion M; 8801015, Federarm AC 2000, 1-3,5 kg 7 polig; 8801016, Federarm AC2000 9-15 kg 5-polig; 8801017, Federarm HELION S Mobile; 8801018, Federarm AC 2000, 12-18 kg 3 polig; 8801019, Federarm AC 2000, 1-3,5 kg 3 polig; 8801020, Federarm AC 2000, 12-18 kg 7 polig; 8801021, Federarm AC 2000, 1-3,5KG, Adapt. Anschl; 8801033, Federarm Deckenanschlu¿ HELS; 8801050, Federarm AC 3000, 12-18 kg ohne Elektr.; 8801051, Federarm SPACE 20-40 kg ohne Elektrik; 8801101, Federarm SWING 2-3 kg 3 POL. 120 Volt; 8801102, Federarm SWING 2-3 kg 3 POL. 230 Volt; 8801103, Federarm f¿r HELION S; 8801104, Federarm SWING 2-3 kg 3 polig; 8807200, Federarm 6.5kg f¿r HELION M+ Mobile; 8894025, Federarm WA 77, 8,3 kg 3 polig; 1425487, FA AC2 STOP 3,5KG - MAX 7KG; 1768718; FA AC 77, NRH 3P; 0385246, FA AC2000 NRH 3P, 12-18KG; 4024790, FA AC3000 NRH 7P; 1419354, FA AC3000 STOP (17 -26KG); 0384021, FA AC2000 NRH MOBIL 3P 12-18KG; 0385247, FA AC2000 NRH MOBIL 7P, 12-18KG; 1695239, ACHSE 1F WL 800, 3P + FA SWING; 1695224, ACHSE 1F ZA 800, 3P + FA SWING; 1886331, BEFESTIGUNGSSET FA AC 77/2000/SWING; and Material #1695225, Description: STATIV MOBIL TL1000, 3P + FA SWING.

General and Plastic Surgery Devices

2

No

Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of Angola, Antilles, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Belgium, Bulgaria, Bahrain, Brasilia, Belarus, Canada, Switzerland, Chile, China, Columbia, Cyprus, Czech Republic, Germany, Denmark, Algerian, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgian Republic, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon, Liechtenstein, Lithuania, Luxembourg, Latvia, Libya, Morocco, Macedonia, Myanmar/Burma, Malta, Mauritius, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Pakistan, Poland, Palestine, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sudan, Sweden, Singapore, Slovenia, Slovakia, San Marino, Syria, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, United Arabian Emirates, Uruguay, Venezuela, British Virgin Islands, Vietnam, Kosovo, Serbia and South Africa.*

Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. || The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

4028110 - iLED Single; 4028210 - iLED duo; 4028310 - iLED trio/quad; 4038110 - TruLight single; 4038210 - TruLight duo; 4038310 - TruLight trio/quad; 1565068 - iLED single (TUSM); 1565160 - iLED duo (TUSM); 1565161 - iLED trio/quad (TUSM); 1574759 - TruLight single (TUSM); 1574850 - TruLight duo (TUSM); 1574851 - TruLight trio/quad (TUSM)

General and Plastic Surgery Devices

2

No

USA (nationwide) Distribution to the states of : AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KY, ME, MA, MN, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WY., and Internationally to Canada.

Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5

Product: Shuttle 2.7, Material Number: 1254362, Serial Number Range: 100801175  101349420; Product: Shuttle 2.7 360, Material Number: 1459862, Serial Number Range: 100843669-101212847; Product: Shuttle 3.7, Material Number: 1254363, Serial Number Range: 100180383-101290987 and Product: Shuttle 3.7 360, Material Number: 1459863, Serial Number Range: 100787418-101334652.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US including MA and TX; Foreign distribution to Austria, Azerbaijan, Belgium, British Virgin Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxemburg, Morocco, Netherlands, New Caledonia, Norway, Poland, Portugal, Qatar, Romania, San Marino, Spain, Sweden and Switzerland.

Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems). || The shuttle is intended for the following applications: 1. Transfer, transport and storage of exchangeable table tops in the Trumpf Medical TruSystem 7500, JUPITER, and SATURN SM operating table systems 2. Patient transport to an operating table top (without a column) from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system 3. Transporting the TruSystem 7500 SM, JUPITER SM or SATURN SM operating table column with table top (without a patient) within the operating theatre.

Bariatric Power Recliner, Product Model # P9096; all power bariatric chairs that are affected by this field action is distributed within the following serial number range:  L341RW9151 through P070RW0812

General Hospital and Personal Use Devices

1

No

Worldwide Distribution - US including AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY, VA Medical Center and Internationally to Canada and Mexico. **Consumer Recommended Depth - Consumers/User**

Hill-Rom Bariatric Power Recliner, Product Model # P9096 || Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.

All Slingbars that are affected by this field action (in the table below) have been distributed within the following serial number range: 1200101 to 1370151  Model Product/Model # Universal SlingBar" 350, 3156074 Universal SlingBar" 350 QRH, 3156084 Universal SlingBar" 350 R2R, 3156094 Universal SlingBar" 450, 3156075 Universal SlingBar" 450 QRH, 3156085 Universal SlingBar" 450 R2R, 3156095 Universal SlingBar" 600 3156076 Universal SlingBar" 600 QRH 3156086

General Hospital and Personal Use Devices

1

No

Worldwide and US Nationwide Distribution AE, AO, AR , AT , AU , AZ , BD , BE , BG , BH , BM , BN , BR , CA , CH , CL , CN , CO , CS , CZ , DE , DK , EG , ES , FI , FR , GB , GR , HK , HR , HU , ID , IE , IL , IN , IR , IS , IT , JO , JP , KR , KW , LB , LI , LK , LT , LU , LV , LY , MA , MT , MX , MY , NL , NO , NZ , OM , PH , PK , PL , PT , QA , RO , RS , RU, SA , SE , SG , SI , SK , SY , TH , TN , TR , TW , UA , US , UY and ZA.

Liko Universal SlingBars || Universal SlingBar" 350, || Universal SlingBar" 350 QRH, || Universal SlingBar" 350 R2R, || Universal SlingBar" 450, || Universal SlingBar" 450 QRH, || Universal SlingBar" 450 R2R, || Universal SlingBar" 600 || Universal SlingBar" 600 QRH || Component of Liko Lifts || Product Usage: || Universal SlingBar 350 It is commonly used for lifting children. Universal SlingBar 350 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 450 Is appropriate in most cases and with most slings. Is installed on most lifts on delivery (does not apply to Viking XL). Universal SlingBar 450 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 600 It is intended for use with the ComfortSling Plus mod 300/310 and 350/360, or with slings the intention of which is to overlap the leg supports, Universal SlingBar 600 is available with two assembly options - fixed assembly and Quick-release Hook (QRH).

All beds (serial numbers) in the 2080, 2082, S 280 and S 282 series are affected by this field action except for those without siderails. The models are as follows: 2080, 2082, 2080 C, 2080 E, 2080 FS, 2080 K, 2080 LP, 2080 MA, 2080 MB, 2080 S, 2080 SL, 2080 SONDER, 2082 SONDER, S280, S280 SONDER, S282, S282 SONDER.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Nationwide and the countries of: Canada, AUSTRALIA, CHINA, HONG KONG, THAILAND, POLAND, RUSSIAN FEDERATION, SLOVENIA, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, ICELAND, IRELAND, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, SPAIN, SWITZERLAND, and UNITED KINGDOM.

Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. || A/C Powered Adjustable Hospital Bed || Product Usage: || Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.

Affected Bed Lot Numbers: R062AA7482 R064AA7505 R042AA7318 R041AA7300 R062AA7483 R064AA7506 R042AA7320 R041AA7302 R062AA7484 R027AA7180 R042AA7321 R041AA7303 R046AA7345 R036AA7274 R042AA7323 R041AA7305 R039AA7278 R041AA7308 R042AA7324 R039AA7279 R039AA7276 R036AA7263 R039AA7281 R046AA7337 R039AA7275 R039AA7284 R046AA7346 R039AA7277 R063AA7503 R053AA7396 R061AA7475 R061AA7471 R053AA7400 R039AA7283 R061AA7472 R053AA7402 R039AA7285 R061AA7473 R053AA7404 R040AA7286 R061AA7474 R042AA7319 R039AA7282 R043AA7325 R046AA7342 R040AA7287 R043AA7327 R050AA7395 R040AA7289 R043AA7328 R056AA7443 R040AA7290 R043AA7329 R061AA7477 R040AA7292 R046AA7336 R040AA7291 R040AA7293 R046AA7339 R040AA7295 R040AA7294 R046AA7338 R041AA7301 R040AA7288 R063AA7492 R041AA7304 R040AA7296 R063AA7493 R041AA7307 R040AA7297 R063AA7494 R041AA7309 R042AA7322 R063AA7495 R041AA7310 R043AA7326 R063AA7496 R041AA7311 R043AA7330 R063AA7497 R041AA7312 R043AA7331 R063AA7498 R042AA7313 R043AA7332 R063AA7501 R042AA7314 R043AA7333 R063AA7502 R042AA7315 R041AA7298 R064AA7504 R042AA7316 R041AA7299

Obstetrical and Gynecological Devices

2

No

US Distribution to the states of : CA, FL, IN, KS, LA, MI, MO, NC, NY, OK, OR, PA, TN, TX, WA, WY Foreign:BULGARIA, INDIA, UNITED ARAB EMIRATES

Affinity Four Birthing Bed Model P3700 || The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping. These are shipped in standard freight containers. There is no secondary packaging.

Serial Numbers - 101281354, 101856082, 101858789, 101858794, 101861232, 101871990, 101871991, 101871994, 101871995, 101871998, 101872002, 101872003, 101875823, 101884649, 101884662, 101890660, 101890661, 101890683, 101895634, 101912771, 101912832, 101912833, 101912837, 101912838, 101916174, 101924149, 101863428, 101875818, 101882033, 101882034, 101882037, 101882038, 101901949, 101901951, 101904490, 101904492, 101907204, 101907205, 101909370, 101909371, 101909372, 101909464, 192052657

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland

Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 || Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system

Serial Numbers - 101863421, 101863427, 101863433, 101875827, 101879148, 101879149, 101882031, 101884650, 101884651, 101884653, 101884654, 101890658, 101890659, 101895636, 101904999, 101907202, 101907203

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland

Stationary Column TruSystem 7599, Material Number 1717020 || Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.

Serial Numbers - 101900011, 101900018, 101904491, 101904998

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland

Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 || Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.

Serial Numbers - 101863316, 101872464, 101879109, 101880571, 101880672, 101880673, 101928935, 101932527, 101937343, 101941055, 101941064, 101941995, 101942798, 101948309, 101954296, 102051758, 102061764, 101926753, 101928934, 101941978, 101941994

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland

Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 || Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system

499633 499694 499274 499367 499410 499383 499479 499573 499615 499634 499695 499275 499368 499411 499384 499480 499574 499616 499635 499696 499276 499369 499412 499385 499481 499575 499617 499636 499697 499277 499370 499413 499386 499482 499576 499618 499637 499698 499278 499371 499414 499387 499483 499577 499619 499638 499699 499279 499372 499415 499388 499484 499578 499620 499639 499700 499280 499323 499416 499389 499485 499579 499621 499640 499701 499281 499324 499417 499390 499486 499580 499622 499641 499702 499282 499325 499418 499391 499487 499581 499623 499659 499703 499283 499326 499419 499392 499488 499582 499624 499660 499704 499284 499327 499420 499393 499471 499583 499625 499661 499705 499285 499328 499421 499394 499472 499584 499626 499662 499706 499286 499329 499422 499395 499489 499585 499627 499663 499707 499287 499330 499423 499396 499490 499586 499628 499664 499708 499288 499331 499424 499397 499491 499587 499629 499665 499709 499289 499332 499425 499440 499492 499588 499630 499666 499710 499290 499333 499426 499441 499493 499589 499552 499667 499298 499291 499334 499427 499442 499494 499590 499553 499668 499299 499292 499335 499428 499443 499495 499592 499554 499669 499300 499293 499336 499429 499444 499496 499593 499555 499671 499301 499294 499337 499430 499445 499497 499594 499556 499672 499302 499295 499338 499431 499446 499498 499595 499557 499673 499303 499296 499339 499432 499447 499499 499596 499558 499674 499304 499297 499340 499433 499448 499500 499597 499559 499675 499305 499348 499341 499434 499449 499501 499598 499560 499676 499306 499349 499342 499435 499450 499502 499599 499561 499677 499307 499350 499343 499436 499451 499503 499600 499562 499678 499308 499351 499344 499437 499452 499504 499601 499563 499679 499309 499352 499345 499438 499453 499505 499602 499564 499680 499310 499353 499346 499439 499454 499506 499603 499565 499681 499311 499354 499347 499468 499455 499507 499604 499566 499682 499312 499355 499398 499469 499456 499508 499605 499567 499683 499313 499356 499399 499470 499457 499509 499606 499568 499684 499314 499357 499400 499373 499458 499510 499607 499569 499685 499315 499358 499401 499374 499459 499511 499608 499570 499686 499316 499359 499402 499375 499460 499512 499609 499571 499687 499317 499360 499403 499376 499461 499473 499610 499538 499688 499318 499361 499404 499377 499462 499474 499611 499539 499689 499319 499362 499405 499378 499463 499475 499612 499540 499690 499320 499363 499406 499379 499464 499476 499631 499541 499691 499321 499364 499407 499380 499465 499477 499632 499542 499692 499322 499365 499408 499381 499466 499478 499613 499543 499693 499273 499366 499409 499382 499467 499572 499614 499544

Neurological Devices

1

No

US Distribution to the state of : FL

Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.

Serial Numbers: 501798, 501799, 501800, 501801, 501802, 501803, 501804, 501805, 501806, 501807, 501808, 501809, 501810, 501811, 501812, 501813, 501814, 501815, 501816, 501817, 501818, 501819, 501820, 501821, 501822, 501823, 501824, 501825, 501826, 501827, 501828, 501829, 501830, 501831, 501832, 501833, 501834, 501835, 501836, 501837, 501838, 501839, 501840, 501841, 501842, 501848, 501849, 501850, 501851, 501852, 501853, 501854, 501855, 501856, 501857, 501863, 501864, 501865, 501866, 501867, 501868, 501869, 501870, 501871, 501872, 501878, 501879, 501880, 501881, 501882, 501883, 501884, 501885, 501886, 501887, 501888, 501889, 501890, 501891, 501892, 501893, 501894, 501895, 501896, 501897, 510733, 510734, 510735, 510736, 510737, 510738, 510739, 510740, 510741, 510742, 510743, 510744, 510745, 510746, 510747, 510748, 510749, 510750, 510751, 510752, 510834, 510835, 510836, 510837, 510838, 510839, 510840

Neurological Devices

1

No

US state of FL

Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 || Product Usage: || The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.

P1900 SN: K328AM6065 to Q245AM0691 PR1900  SN: L082AL7316 to R343AL4516 U1900  SN: L257AM0541 to O311AM7169 Scale Upgrade Kit P1957A produced after March 13, 2013 (not serialized).

General Hospital and Personal Use Devices

2

No

US Nationwide. AUSTRALIA BANGLADESH BRAZIL CANADA CHINA GERMANY INDIA ITALY KUWAIT PAKISTAN SAUDI ARABIA THAILAND UNITED ARAB EMIRATES CYPRUS GREECE NETHERLANDS

TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).

Lot Number 0715: Serial Number range (21)07150001 -  (21)07150620; Lot Number 1215: Serial Number range (21)12150001 -  (21)12150500; --- Note: (21) is NOT part of the serial number. It is the Global Unique Device Identification (GUDI) Application Identifier that precedes the serial number on any GUDI compliant label.

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) Distribution

Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland

Catalog Number 1940747, All serial numbers: 102584474, 102584475, 102584477, 102584478, 102805330, 102813656, 102813657, 102813658, 102813659, 102813660, 102813661, 102813662, 102860647, 102860652, 102863706, 102863707, 102867783, 102867784, 102925734, 102925735, 102925736, 102925737, 102925738, 102925739, 102925740, 102925741, 102925742, 102925743, 102928703, 102932185, 102932186, 102932187, 102932188, 102932189, 102932203, 102932204, 102932205, 102932206, 102932207, 102932208, 102932209, 102932210, 102932211, 102932212, 102932217, 102932218, 102932219, 102932220, 102932221, 102932223, 102934525, 102934526, 102934527, 102934528, 102934529, 102936117, 102939484, 102940382, 102940383, 102940384, 102940386, 102940387, 102940388, 102940389, 102940390, 102940391, 102940408, 102940409, 102940410, 102961390, 102961391, 102961392, 102961393, 102961394, 102961395, 102961396, 102961397, 102961398, 102961399, 102961400, 102961401, 102975336, 102986494, 102986495, 102988480, 102989096, 102989607, 102989608, 102989615, 102990285, 102990286, 102994502, 102994503, 102994504, 102994505, 102994506, 102994525, 102994526, 102994529, 102994530, 102996306, 103005879, 103005880, 103005889, 103005890, 103005891, 103005892, 103005893, 103006636, 103010023, 103010759, 103010760, 103010761, 103010762, 103010763, 103012786, 103012787, 103013644, 103017040, 103017041, 103019900, 103020713, 103022348, 103022349, 103022350, 103022351, 103022352, 103022794, 103024049, 103024050, 103030284, 103031623, 103034106, 103034109, 103038842, 103038843, 103038844, 103038845, 103038846, 103038847, 103038848, 103038849, 103038850, 103038853, 103038854, 103038855, 103038856, 103038857, 103038858, 103038859, 103038860, 103038861, 103038862, 103038863, 103038864, 103038865, 103038866, 103039468, 103042319, 103042320, 103042321, 103042322, 103042925, 103042926, 103046119, 103046120, 103046121, 103046122, 103046123, 103046124, 103046125, 103046126, 103046127, 103046128, 103046129, 103046130, 103048248, 103065061, 103070795, 103070796, 103070797, 103070798, 103079001, 103079053, 103087365, 103087366, 103087367, 103087368, 103087369, 103087370, 103087371, 103090135, 103090136, 103090137, 103091507, 103091508, 103091509, 103091510, 103091511, 103095664, 103101676, 103101826, 103101864, 103101886, 103103841, 103103842, 103103843, 103103844, 103103845, 103104556, 103113059, 103117961, 103118986, 103118987, 103118988, 103118989, 103118990, 103118991, 103118992, 103118993, 103118994, 103118995, 103123759, 103133224, 103134656, 103138822, 103143214, 103149993, 103164298, 103168053, 103168341, 103168431, 103176559, 103176571, 103176574, 103191728, 103191729, 103194419, 103214005, 103214022.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Distribution to the states of : GA, IL, IN, PA, SC, TX, UT, VA. and to the countries of : Austria, Australia, Bangladesh, Belgium, France, Switzerland, Czech Republic, Germany, Denmark, Spain, United Arab Emirates, United Kingdom, Ireland, Italy, Kuwait, Lithuania, Poland, Portugal, Romania, Sweden, Slovenia, Thailand, Turkey.

Camera System, Television, Surgical without audio || Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.

S159AW9192 through S305AW2321 Beds manufactured from June 8, 2017 to November 1, 2017

General Hospital and Personal Use Devices

2

No

Worldwide distribution. US nationwide, Canada, Chile, Colombia, Costa Rica, France, Hong Kong, Israel, Jamaica, Japan, Jordan, Malaysia, Mexico, Oman, Panama, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, UAE, and UK.

Progressa Bed - AC-powered adjustable hospital bed

Serial Numbers:  A166677 A201568 A311424 A333604 A353171 A385408 A166678 A201569 A311425 A339446 A357145 A385409 A170724 A201570 A314187 A339447 A359864 A385410 A179337 A209110 A319402 A348001 A362219 A386775 A182027 A209111 A320583 A348174 A364982 A386776 A183578 A209112 A320584 A348175 A369558 A386777 A188535 A209113 A322480 A348176 A369884 A386778 A194789 A282259 A322597 A348177 A370262 A390698 A194790 A282260 A325663 A348178 A372387 A390699 A197337 A282537 A325664 A348179 A378593 A390700 A197338 A282538 A326358 A352174 A378594 A390701 A197339 A309460 A331161 A352175 A378595 A390702 A197554 A309461 A331162 A352176 A378596 A390703 A198334 A309462 A331163 A352177 A378597 A395121 A198335 A309463 A333601 A353168 A384029 A395122 A198336 A309464 A333602 A353169 A384329 A395123 A201567 A309465 A333603 A353170 A384330

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, France, Saudi Arabia, Germany, and France.

F-T3SYSTEM, T3 (Trumpf Table Top) System || The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,

Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)

Cardiovascular Devices

2

No

Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.

NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn label with Part #5082-101-1, and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - firm on label is Welch Allyn, Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #30502-110S, firm on label is Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #5084-101-1, firm on label is Arden, Skaneateles, NY.

Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)

Cardiovascular Devices

2

No

Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.

NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part #s 5082-101-2, 5082-101-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #s 30502-110 and 30502-210 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #s 5084-101-2 and 633-5084-101-2 - Arden, Skaneateles, NY.

Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)

Cardiovascular Devices

2

No

Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.

NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-102-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-111S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-102-1 - Arden, Skaneateles, NY.

Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)

Cardiovascular Devices

2

No

Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.

NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-102-2, 5082-102-2CL, 671-5082-102-2, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-111 and 30502-211 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-102-2 and 634-5084-102-2 - Arden, Skaneateles, NY.

Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)

Cardiovascular Devices

2

No

Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.

NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-1 - Arden, Skaneateles, NY.

Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)

Cardiovascular Devices

2

No

Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.

NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-2, 5082-102-2CL , and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112 and 30502-212 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-2, and 635-5084-103-2 - Arden, Skaneateles, NY.

Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)

Cardiovascular Devices

2

No

Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.

NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-104-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-113S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-104-1 - Arden, Skaneateles, NY.