Device Recall MRI

  • Model / Serial
    Medical Device Listing No. D117354, D295466, D182389, D102432, D206140, D230310, D269569, D102430, D140572, D188736, D102434, D234841, D196247, D134019, D236543, D006275, D159181, D288890, D229859; Model No. Eaton 9130, 5323286, 5396502-5, 5499460-3, 5499460-6, 5499460-9, 5741000-3, 00840682115971, 5396502-2, 5499460-2, 5741000-2, 00840682115872, 5373011-3, 5396469-3, 5481490-2, 5481500-7, 5499460-7, 5499460-10, 5741000, 00840682103817, 5323286-101, 2377062-61, 2395001, 2395001-2, 2395001-3, 2395001-4, 00840682105699, 840682105378
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI
  • Product Description
    Signa PET/MR (K163619, K142098) || Product Usage: || The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiationfree attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
  • Manufacturer
  • 9 Events

Manufacturer

  • Manufacturer Address
    GE Medical Systems, LLC, 3200 N Grandview Blvd, Waukesha WI 53188-1693
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog/Part Number: 10000; Serial Numbers: 100, 101, 102, & 105
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, MO and WI., and Internationally to Korea.
  • Product Description
    MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ || Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
  • Manufacturer
  • Model / Serial
    Serial Numbers:  US00200747 US00200119 US00200132 US00200133 US00200134 US00200135 US00200136 US00200139 US00200140 US00200141 US00200142 US00200143 US00200144 US00200162 US00200163 US00200164 US00200165 US00200166 US00200167 US00200168 US00200169 US00200170 US00200171 US00200172 US00200173 US00200192 US00200193 US00200194 US00200195 US00200196 US00200197 US00200219 US00200220 US00200221 US00200222 US00200223 US00200224 US00200238 US00200239 US00200240 US00200241 US00200242 US00200243 US00200258 US00200259 US00200260 US00200261 US00200262 US00200263 US00200283 US00200284 US00200285 US00200286 US00200292 US00200293 US00200294 US00200295 US00200296 US00200299 US00200300 US00200301 US00200302 US00200343 US00200344 US00200345 US00200352 US00200354 US00200361 US00200362 US00200371 US00200372 US00200381 US00200382 US00200383 US00200393 US00200394 US00200395 US00200396 US00200399 US00200434 US00200435 US00200436 US00200454 US00200455 US00200456 US00200457 US00200458 US00200459 US00200528 US00200529 US00200530 US00200531 US00200532 US00200557 US00200558 US00200560 US00200561 US00200562 US00200563 US00200564 US00200565 US00200566 US00200567 US00200568 US00200569 US00200600 US00200601 US00200602 US00200603 US00200619 US00200621 US00200636 US00200667 US00200668 US00200669 US00200670 US00200671 US00200672 US00200673 US00200674 US00200687 US00200688 US00200689 US00200690 US00200709 US00200726 US00200727 US00200729 US00200736 US00200737 US00200742 US00200743 US00200744 US00200745 US00200746 US00200749 US00200750 US00200770 US00200780 US00200784 US00200785 US00200812 US00200823 US00200824 US00200827 US00200828 US00200829 US00200830 US00200831 US00200851 US00200865 US00200866 US00200872 US00200873 US00200888 US00200889 US00200890 US00200891 US00200892 US00200893 US00200907 US00200908 US00200909 US00200915 US00200916 US00200917 US00200918 US00200919 US00200920 US00200921 US00200922 US00200923 US00200932 US00200933 US00200958 US00200959 US00200960 US00200961 US00200966 US00200967 US00200968 US00200975 US00200977 US00200978 US00200984 US00200990 US00201002 US00201003 US00201022 US00201023 US00201024 US00201025 US00201053 US00201054 US00201055 US00201056 US00201057 US00201058 US00201065 US00201066 US00201067 US00201068 US00201112 US00201113 US00201114 US00201115 US00201116 US00201117 US00201118 US00201131 US00201132 US00201133 US00201135 US00201137 US00201146 US00201147 US00201148 US00201149 US00201150 US00201151 US00201152 US00201162 US00201210 US00201213 US00201214 US00201215 US00201216 US00201217 US00201219 US00201221 US00201222 US00201223 US00201224 US00201225 US00201226 US00201227 US00201229 US00201230 US00201251 US00201252 US00201253 US00201254 US00201255 US00201256 US00201257 US00201258 US00201259 US00201260 US00201261 US00201262 US00201297 US00201298 US00201299 US00201300 US00201301 US00201302 US00201303 US00201304 US00201305 US00201306 US00201364 US00201365 US00201368 US00201381 US00201382 US00201383 US00201384 US00201385 US00201386 US00201388 US00201389 US00201408 US00201409 US00201417 US00201451 US00201452 US00201453 US93600111 US93600112 US93600113 US93600114 US93600142 US93600144 US93600167 US93600170
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI., SC, SD, TN, TX, VA, WA, and WI and the countries of: Australia, Austria, Canada, Denmark, Germany, Israel, Malaysia, Netherlands, Norway, Singapore, Spain, Switzerland and, United Kingdom.
  • Product Description
    "***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564155341***SN US11401652***". || Note: REF 453564155341, REF 453564181201, and 453564180091 are subject to recall. REF is the firms Service Number which identifies the device. || Product Usage The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization of the MR scanner.
  • Manufacturer
  • Model / Serial
    The device Lot Code is LBG001. The "L" indicates facility, Las Piedras Facility. The "B" indicates year manufactured, 2012. The "G" indicates month manufactured, July. The "001" indicates the sequential lot build, restarts at 1 every month.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX.
  • Product Description
    The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. || Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, do not resterilize, and is available only by prescription. Device made in U.S.A. by Iradimed Corporation located in Winter Park, FL 32792. Lot LBG001, Exp 07/2016 || The MRidium MRI Infusion Pumps and Infusion Sets are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans. The device is available for sale only upon the order or a physician or other related licensed medical professional, and not intended for any home use applications.
  • Manufacturer
  • Model / Serial
    Part number 1145 Lots: 4501,4510, 4538, 4587, 4596, 4675, 4690, 4705, 4738, 4748, 4960, 4970, 5001, 5065, 5104, 6164, 5221, 5240, 5349, 5361, 5517, 5737, 5764, 5881, 6006, 6151, 6170, 6180, 6252, 6470, 6583, 6806, 6881, 6984, and 7213.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, and WA; and countries of: Australia, Austria, Denmark, Epsom, France, Germany, London, Netherlands, Saudia Arabia, and United Kingdom.
  • Product Description
    MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). || The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans.
  • Manufacturer
  • Model / Serial
    Lot REXC0931 and REXC0736
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide, Belgium, and Canada.
  • Product Description
    MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. || Product Usage: || The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percutaneous needle insertion using a non-coring needle. The system consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque silicone catheter.
  • Manufacturer