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Name Date Date initiated Country Source
Safety Alert for Commercial Name: System for Bucco Maxillofacial Osteosynthesis. Technical Name: System for Bucco-Maxillofacial Osteosynthesis. ANVISA registration number: 80389000007. Risk class: III. Model affected: 16.511 Intermaxillary Locking Screw 2.0 X 8.0mm. Lots / series numbers affected: 47632 2018-04-26 Brazil ANVISA
Safety Alert for Trade name: Somatom Emotion computed tomography equipment. Technical name: CT Scanner. ANVISA registration number: 10345161972. Risk class: III. Model affected: SOMATOM Emotion 16 (2007); SOMATOM Emotion 16 Slice (BR); SOMATOM Emotion 6 (2007); SOMATOM Emotion 6 Slice (BR). Affected serial numbers: See "List of Series Under Risk" annex. . Trade name: CT Scanner Somatom Spirit Brand Siemens. Technical name: CT Scanner. ANVISA registration number: 10345162002. Class of risk: III. Model affected: SOMATOM Spirit (BR); SOMATOM Spirit; SOMATOM Spirit Power; SOMATOM Spirit Power (BR). Affected serial numbers: See "List of Series Under Risk" annex. . Trade name: Somatom Scope Power CT Scanner. Technical name: CT Scanner. ANVISA registration number: 10345161975. Class of risk: III. Model affected: SOMATOM Scope (BR); SOMATOM Scope Power (BR); SOMATOM Scope. Affected serial numbers: See "List of Series Under Risk" annex. . Trade name: CT Scanner Somatom Perspective. Technical name: CT Scanner. ANVISA registration number: 10345162001. Risk class: III. Affected Model: SOMATOM Perspective 64/128 (BR); SOMATOM Perspective. Affected serial numbers: See annex "Series List Under Risk" 2018-04-26 Brazil ANVISA
Safety Alert for Trade name: Inorganic fabric - Dynamesh PR2 Soft type 2B 10x6cm. Technical name: Dynamesh PR2 Soft 2B 10x6cm. ANVISA registration number: 80299880023. Risk class: III. Model affected: Dynamesh PR. Lot Number / Series Affected: Lot Number: 3013/575/6 2018-04-26 Brazil ANVISA
Safety Alert for Trade name: Inorganic fabric - Dynamesh PR4 Soft type 2B - PVDF. Technical name: Dynamesh PR4 Soft 2B 9x6cm. ANVISA registration number: 80299880023. Risk class: III. Model affected: Dynamesh PR. Lot Numbers / Series Affected: Lot Number: 0714/613/6 2018-04-26 Brazil ANVISA
Safety Alert for Commercial name: Bone Densitometry / Densitometer Osseo Lunar Dpx / Osseo Lunar Densitometer Dpx / Bone Densitometer Prodigy. Technical Name: Bone Desensiometry Apparatus. ANVISA registration number: 80071260174; 80071260176; 80035360019; 80071260163 ;. Risk class: III. Affected Model: DPX Bravo, DPX-Duo (80071260174) / DPX-NT (80071260176) / DPX-MD + (80035360019) / Prodigy, Prodigy Advance (80071260163). Lots of numbers affected: PA + 130268; LNR41569; LNR74315; LNR150180; LNR73479 2018-04-26 Brazil ANVISA
Safety Alert for Commercial Name: Angiographic X-ray System / Image Guided System / Innova Cardiovascular Imaging System. Technical Name: Hemodynamics and Angiography Equipment / Angiography Equipment / Angiography Equipment. ANVISA registration number: 80071260269. Risk class: III. Model affected: Discovery IGS IGS 730, Discovery IGS 740 (80071260304) / Innova IGS 520, Innova IGS 530, Innova IGS 540 (80071260269) / Innova IGS 620, Innova IGS 630 (80071260305). Number of Batch / Series Affected: Discovery IGS IGS 730, Discovery IGS 740 (80071260304) / Innova IGS 520, Innova IGS 530, Innova IGS 540 (80071260269) / Innova IGS 620, Innova IGS 630 (80071260305) 2018-04-20 Brazil ANVISA
Safety Alert for Trade name: GE T2100 Ergometer Treadmill. Technical Name: Treadmill. ANVISA Registration Number: 80071260189. Hazard Class: I. Affected Model: GE T2100 Ergometer Treadmill. Batch / Affected Series Numbers: GE T2100 Ergometer Treadmill 2018-04-20 Brazil ANVISA
Safety Alert for Trade name: Stonebreaker-Lithotriptor Pneumatic. Technical name: Lithotripsy / Urology / Gatroenterology System. ANVISA registration number: 10330710088. Class of risk: III. Affected Model: Hardware: SBL-KIT1. Accessories and parts: SBP-010500, SBP-010605, SBP-016500, SBP-016605, SBP-020425, SBA-EC, SBA-EL, SBA-PC, SBA-SC and SBC-10 .. affected. Reference SBL-KIT1: 0900270, 0900468, 5054460, 5054461, 5684194, NS5784309, NS5784311, NS5784311, NS5784312, NS5784313, NS5784315, NS5784315, NS5784316, NS5784317, NS5784318, NS5792890, NS5792891, NS5792892, NS5792893, NS5792894, and 5873311X .. SBA Reference -EC: 6241349 .. SBA-PC Reference: 5257852 and 5943831 .. SBA-SC Reference: 5924492 .. SBC-10 Reference: 09020, 4982708, U2462535, U2466275, U2466279, 5296161, 5282743, 5296161, 591920, 5919200, 5919201 , 6292892, 6292896, 6292892, and 6292896. Referring to SBP-010500: 09054, U2467239 and U2476031 .. Reference SBP-010605: U2473998, 5616732, 5676478, 5716379, 5884345, 5898498 .. Reference SBP-016500: 5000020 and 6028035 .. Reference SBP-016605: 09022, U2427745 and U2458178. Reference SBP-020425: U2067690, 5000021, U2467237, U2467241, 5676479, 5898500, 5925167, 6810029, 7081752 and 7378379. 2018-04-20 Brazil ANVISA
Safety Alert for Trade name: Blood Line for Hemodialysis. Technical Name: Hemodialysis Equipment. ANVISA registration number: 80133950083. Risk class: II. Model affected: Arterial without catabolha. Lot / Affected Series Numbers: Lot: 03717, 07217, 07717, 08517, and 09417 2018-04-20 Brazil ANVISA
Safety Alert for Trade name: ID-Card Diaclon Abo / D + Proof Reversal. Technical Name: Immunohematology - ABO - Monoclonal Origin. ANVISA registration number: 80004040061. Risk class: IV. Affected model: 00 000 000 0012 35. Lot numbers / series affected: Lot: 50092.95.19 - ID-Card numbering sequence from 23,000 to 31,000 2018-04-19 Brazil ANVISA
Safety Alert for Commercial name: Set of instruments for trauma surgery Zimmer. Technical Name: Instrumental Kit. ANVISA Registration Number: 80044680331. Hazard Class: I. Model Affected: 47-2255-008-01; 47-2490-097-00; 47-2490-097-01; 47-2490-098-00; 47-2490-098-01. Lots of numbers affected: 63696961; 6,372,371; 6,370,523; 77006549; 63668698; 63748390; 63748391. 2018-04-19 Brazil ANVISA
Safety Alert for Trade name: OneHbA1c IS. Technical Name: Glycosylated hemoglobin. ANVISA registration number: 10350840200. Class of risk: II. Affected Model: 100 cartridges (R1: 350uL / R2: 75uL / R3: 80uL) + 10 Cleaner Tubes (1800uL) + Paramcard Card. Lots of numbers affected: 60121004; 6,011,9264; 60119656; 60121001 2018-04-19 Brazil ANVISA
Safety Alert for Product Category: Angiography Equipment Allura Xper. Technical Name: Angiography Equipment. ANVISA registration number: 10216710153. Class of risk: III. Affected Model: Allura Xper FD10 Ceiling / Allura Xper FD10 Ceiling / Allura Xper FD10 Ceiling / Allura Xper FD10 Ceiling / Allura Xper FD10 Serial numbers affected: 947 2018-04-17 Brazil ANVISA
Safety Alert for Business Name: HeartMate 3 - Left Ventricular Assist System. Technical Name: Other Cardiovascular Implants. ANVISA registration number: 10332340428. Class of risk: IV. Affected Model: HeartMate 3. Serial Numbers Affected: Model: 10010167 - Series Numbers: MLP-009201; MLP-009203; MLP-009205, MLP-009206; MLP-009207; MLP-009667 2018-04-17 Brazil ANVISA
Safety Alert for Trade name: Ureterorenofibroscope. Technical Name: Ureterorenofibroscope. ANVISA registration number: 80124630193. Class of risk: II. Model affected: URF-P6 / P6R. Affected serial numbers: 2613119, 2613237,2613239, 2612933, 2612936, 2612947, 261H189,2613101, 2612937, 2613240, 2613102, 2613844, 2613861, 2613846, 2613847, 2613848, 2613845, 2613864, 2613866, 2612931, 2613077, 2613843. 2018-04-17 Brazil ANVISA
Safety Alert for Commercial Name: PR4100 Microplate Reader. Technical name: Instrument for immunoassays. ANVISA registration number: 80020690326. Class of risk: II. Model Affected: 00 000 000 094196. Serial numbers affected: 1702001988; 1702001989; 1702001995; 1701004076; 1701004078; 1701004079; 1701004087; 1611001407; 1701004096; 1601004139; 1601004146. 2018-04-17 Brazil ANVISA
Safety Alert for Trade name: PTS PANELS CHOL + GLU Test Panel Test Strips. Technical Name: Total Cholesterol. ANVISA registration number: 80812770002. Class of risk: II. Affected model: 1 box with 1 vial with 25 strips of analysis and desiccant, 1 microprocessor MEMo CHIP>. Serial numbers affected: A707 2018-04-17 Brazil ANVISA
Safety Alert for Trade name: Surgical Focus Rolite Volista Standop. Technical Name: Surgical Focus. ANVISA registration number: 80259110090. Risk class: I. Model affected: Rolite Volista 400; Rolite Volista 600. Series numbers affected: All VOLISTA StandOP / TRIOP domes, manufactured until 06/2017 and equipped with the ARD568801560 keypad. 2018-04-17 Brazil ANVISA
Safety Alert for Trade name: Azurion. Technical name: Hemodynamic and Angiography equipment. ANVISA registration number: 10216710345. Risk class: III. Affected model: 3 and 7. Serial numbers affected: 151; 152; 295; 383 2018-04-16 Brazil ANVISA
Safety Alert for Commercial Name: BD Vacutainer Plastic Tube with Reagent for Vacuum Blood Coke. Technical name: Vacuum blood collection tube. ANVISA registration number: 10033430470. Hazard class: I. Model affected: TUBE VACUTAINER SST TAMPA HEMOGARD 3,5mL. Batch / Affected Series Numbers: 7125692 and 7135828 2018-04-06 Brazil ANVISA
Safety Alert for Trade name: Disposable Barrx. Technical Name: Radiofrequency Tips for Surgery. ANVISA registration number: 10349000491. Risk class: III. Affected Model: 64082. Affected Batches / Series Numbers: F2502807X; F2503073X; F2503284X; 2018-04-06 Brazil ANVISA
Safety Alert for Trading name: Cobas e801 Module. Technical name: Instrument for immunoassays. ANVISA registration number: 10287411196. Class of risk: II. Model affected: -. Lots / series numbers affected :. 1741-08 (Roche), 1765-02, 1766-04, 1766-05, 1768-07, 1768-08, 1768-09, 1767-08, 1768-10, 1767-07, 1772-04, 1771-03 , 1771-06, 1787-10, 1788-01, 1791-06, 1791-07, 1796-09, 1796-10, 1797-04, 1799-04, 1799-05, 18E0-04 (Roche) and 18E0- 05 (Roche) 2018-04-06 Brazil ANVISA
Safety Alert for Trade name: Ingenuity CT. Technical name: CT Scanner. ANVISA registration number: 10216710209. Risk class: III. Model Affected: Ingenuity CT / Ingenuity Flex. Lots of lots / series affected: 310375 2018-04-06 Brazil ANVISA
Safety Alert for Trade name: Femoral Head Modular. Technical name: Hip prosthesis. ANVISA registration number: 10223710079. Risk class: III. Affected Model: Interchangeable Head Cone 12/14 22 S. Affected Batches / Series Numbers: 1660G17; 1662G17; 1630G17; 3548H17; 3553H17; 3554H17; 1579L17 Brazil ANVISA
Safety Alert for Trade name: Steam Sterilizers GSS67F. Technical Name: Autoclave. ANVISA registration number: 80259110142. Hazard class: II. Model Affected: GSS6710; GSS6713. Lots of numbers affected: 0011218904-010-01; 0011218904-060-01; 0011207210-010-02; 0011207210-060-01; 0011207210-010-01; 0011220774-010-01; BAA083638; BAA083636; BAA083637; BAA083635 2018-04-06 Brazil ANVISA