Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-1547-2009 | BrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC, model... | Brainlab, Inc. | IYE | ||
| Z-1546-2009 | BrainLab M3 Micro-Multileaf-Collimator for Siemens Mevatron Digital Type III with MLC... | Brainlab, Inc. | IYE | ||
| Z-1545-2009 | BrainLab m3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3... | Brainlab, Inc. | IYE | ||
| Z-1228-2010 | 10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial... | Ortho Development Corp. | JWH | ||
| Z-1544-2009 | BrainLab Micro-Multileaf-Collimator, model 41600; BrainLab AG, Kapellenstrasse 12, 85622... | Brainlab, Inc. | IYE | ||
| Z-1347-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#... | Boston Scientific Corporation | FAD | ||
| Z-1346-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#... | Boston Scientific Corporation | FGE | ||
| Z-1345-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN... | Boston Scientific Corporation | FGE | ||
| Z-1344-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | FGE | ||
| Z-1343-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | FGE | ||
| Z-1342-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | FAD | ||
| Z-1341-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | FGE | ||
| Z-1340-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | FFA | ||
| Z-1339-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | GBO | ||
| Z-1338-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | FGE | ||
| Z-1337-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | FGE | ||
| Z-1485-2009 | Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 0, TIB B/PL... | Zimmer GmbH | JWH | ||
| Z-1484-2009 | Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 0, TIB B/PL... | Zimmer GmbH | JWH | ||
| Z-1483-2009 | Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 00, for... | Zimmer GmbH | JWH | ||
| Z-1482-2009 | Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Left, Size 00, for... | Zimmer GmbH | JWH | ||
| Z-1336-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | FGE | ||
| Z-1335-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | FGE | ||
| Z-1334-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | GBW | ||
| Z-1333-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | FFA | ||
| Z-1332-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | FFA | ||
| Z-1331-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)... | Boston Scientific Corporation | FFA | ||
| Z-0653-2010 | Edwards Lifesciences Aquarius System Model GEF09800. | Edwards Lifesciences LLC | KDI | ||
| Z-1828-2011 | Phoenix x/ray nanotom series. Phoenix x|ray nanotom series cabinet x-ray systems are... | GE Inspection Technologies, LP | RCE | ||
| Z-1827-2011 | Phoenix x/ray v/tome/x series. Phoenix x|ray v|tome|x series cabinet x-ray systems are... | GE Inspection Technologies, LP | RCE | ||
| Z-1826-2011 | Phoenix x/ray inspector series. Phoenix x|ray inspector series cabinet x-ray systems are... | GE Inspection Technologies, LP | RCE | ||
| Z-1825-2011 | Phoenix x/ray analyser series. Phoenix x|ray analyser series cabinet x-ray systems are... | GE Inspection Technologies, LP | RCE | ||
| Z-1614-2009 | Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile, Biomet... | Zimmer GmbH | LZO | ||
| Z-1613-2009 | Biomet Biolox-Delta Modular Ceramic Head, 28 mm head diameter, plus 5 neck, type 1... | Zimmer GmbH | LZO | ||
| Z-1421-2009 | NeuroStar TMS Therapy System/SenStar Treatment Link. The SenStar Treatment Link is a... | Neuronetics Inc. | OBP | ||
| Z-2053-2009 | Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and... | Natus Medical Incorporated | JXG | ||
| Z-0909-2011 | CyberKnife System Robotic Radiosurgery System, (Robocouch Patient positioning System)... | Accuray Incorporated | IYE | ||
| Z-0908-2011 | CyberKnife System Robotic Radiosurgery System, (Standard Treatment Couch) Synchrony... | Accuray Incorporated | IYE | ||
| Z-1250-2009 | Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM... | Cardiovascular Systems Incorporated | MCW | ||
| Z-1264-2009 | Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter... | Spectranetics Corp. | OEX | ||
| Z-1258-2011 | FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose... | Abbott Medical | NBW | ||
| Z-1262-2009 | Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile... | Zimmer GmbH | HTQ | ||
| Z1006-2010 | FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number... | Roche Molecular Systems Inc | NPR | ||
| Z-2223-2009 | BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical... | Agilent Technologies, Inc. | JJQ | ||
| Z-1259-2009 | GE Healthcare CT Systems Table Model Number 2269165 used on LightSpeed 1X through 4X and... | GE Healthcare | JAK | ||
| Z-1258-2009 | GE Healthcare CT Systems Table Model Number 2271242 used on LightSpeed 1X through 4X and... | GE Healthcare | JAK | ||
| Z-1257-2009 | GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and... | GE Healthcare | JAK | ||
| Z-1470-2009 | Boston Scientific Wiseguide Guide Catheter, Sterilized. Wiseguide catheters are... | Boston Scientific Corporation | DQY | ||
| Z-1649-2009 | Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-1648-2009 | Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-1600-2009 | GE Healthcare CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1... | GE Healthcare | DSI |