Hologic, Inc. Recall 91415
Description: Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D
Hologic, Inc. Recall 91415 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1144-2023 |
| Event ID | 91415 |
| Event Description | Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 797 units |
| Recall Reason | C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual |
| Device Classification | 20230301 |
| Device Code Info | UDI: 15420045508019; 15420045505636 Serial Numbers; 81001090068 81001100177 81001110594 81001110612 81001110627 81001121279 81001132051 81001132057 81001132096 81001142983 81001142990 81001142995 81001143035 81001143051 81001143060 81001143068 81001143071 81001154286 81001154309 81001154310 81001154320 81001154322 81001154340 81001165989 81001165997 81001165999 81001166000 81001166015 81001166073 81001166090 81001166094 81001166098 81001166109 81001166119 81001166124 81001177755 81001177759 81001177764 81001177803 81001177809 81001177819 81001177820 81001177822 81001177826 81001177829 81001177832 81001177844 81001177851 81001177853 81002100189 81002100197 81002110651 81002110662 81002110663 81002110664 81002121291 81002121328 81002132113 81002143090 81002143092 81002143112 81002143142 81002143144 81002143146 81002143151 81002154368 81002154378 81002154384 81002154388 81002154403 81002154405 81002154434 81002154449 81002154452 81002154459 81002154466 81002154467 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SDM131901528 SDM131901625 SDM131901761 SDM132700105 SDM181700182 |
| Center Classification Date | 20230221 |
| Recall Initiation Date | 20230116 |
| Recalling Firm | Hologic, Inc. |
| Initial Notification | Letter |
| Similar To |