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-1775-2015 | Class II | AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray... | Philips North America LLC | KPS | |
| Z-1774-2015 | Class II | FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray... | Philips North America LLC | KPS | |
| Z-1773-2015 | Class II | Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography... | Philips North America LLC | JAK | |
| Z-1772-2015 | Class II | Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | JAK | |
| Z-1771-2015 | Class II | Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography... | Philips North America LLC | JAK | |
| Z-1770-2015 | Class II | Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography... | Philips North America LLC | JAK | |
| Z-1769-2015 | Class II | iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray... | Philips North America LLC | JAK | |
| Z-1768-2015 | Class II | Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography... | Philips North America LLC | JAK | |
| Z-1767-2015 | Class II | Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices)... | Philips North America LLC | JAK | |
| Z-1766-2015 | Class II | Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | JAK | |
| Z-1765-2015 | Class II | Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices)... | Philips North America LLC | JAK | |
| Z-1764-2015 | Class II | Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices)... | Philips North America LLC | JAK | |
| Z-1763-2015 | Class II | Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | JAK | |
| Z-1762-2015 | Class II | Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | JAK | |
| Z-1761-2015 | Class II | Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supply (UPS)... | Philips North America LLC | JAK | |
| Z-1760-2015 | Class II | MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed... | Philips North America LLC | JAK | |
| Z-1759-2015 | Class II | MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography... | Philips North America LLC | JAK | |
| Z-1582-2015 | Class II | ExacTrac 6.x. is software used to place patients at an accurately defined point within... | Brainlab, Inc. | IYH | |
| Z-1500-2015 | Class II | CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use. | Wright Medical Technology Inc | HRS | |
| Z-1499-2015 | Class II | CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7. Orthopedic use. | Wright Medical Technology Inc | HRS | |
| Z-1498-2015 | Class II | CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use. | Wright Medical Technology Inc | HRS | |
| Z-1497-2015 | Class II | CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use. | Wright Medical Technology Inc | HRS | |
| Z-1496-2015 | Class II | CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use. | Wright Medical Technology Inc | HRS | |
| Z-1495-2015 | Class II | CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use. | Wright Medical Technology Inc | HRS | |
| Z-1494-2015 | Class II | CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use. | Wright Medical Technology Inc | HRS | |
| Z-1493-2015 | Class II | CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use. | Wright Medical Technology Inc | HRS | |
| Z-1492-2015 | Class II | CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use. | Wright Medical Technology Inc | HRS | |
| Z-1491-2015 | Class II | CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use. | Wright Medical Technology Inc | HRS | |
| Z-1490-2015 | Class II | CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use. | Wright Medical Technology Inc | HRS | |
| Z-1489-2015 | Class II | CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF... | Wright Medical Technology Inc | HRS | |
| Z-1488-2015 | Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF... | Wright Medical Technology Inc | HRS | |
| Z-1487-2015 | Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF... | Wright Medical Technology Inc | HRS | |
| Z-1486-2015 | Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF... | Wright Medical Technology Inc | HRS | |
| Z-1485-2015 | Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF... | Wright Medical Technology Inc | HRS | |
| Z-1484-2015 | Class II | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L. Orthopedic... | Wright Medical Technology Inc | HRS | |
| Z-1483-2015 | Class II | CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic... | Wright Medical Technology Inc | HRS | |
| Z-1482-2015 | Class II | CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use. | Wright Medical Technology Inc | HRS | |
| Z-1526-2015 | Class II | VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model... | LivaNova USA, Inc. | LYJ | |
| Z-1370-2015 | Class II | BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use. | Becton, Dickinson and Company, BD Biosciences | OYE | |
| Z-1367-2015 | Class II | YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment... | Nidek Incorporated | LXS | |
| Z-0399-2017 | Class II | Merge LIS software. | Merge Healthcare Incorporated | JQP | |
| Z-1663-2015 | Class II | Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1662-2015 | Class II | Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1661-2015 | Class II | Direct Water feed Kit, Catalog#10373222 | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1660-2015 | Class II | Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1659-2015 | Class II | Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1658-2015 | Class II | Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1458-2015 | Class II | Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs... | GE Healthcare | CBK | |
| Z-1514-2015 | Class II | Sony Medical Monitor LMD-1951MD 19 inch | Sony Latin America Inc | KQM | |
| Z-1690-2015 | Class II | HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product... | Maquet Cardiovascular Us Sales, LLC | DTQ |