Recall Z-1144-2023 ยท OTE Digital Breast Tomosynthesis
Hologic, Inc.
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-
| Date | Feb 21, 2023 (initiated Jan 16, 2023) |
| Status | Open, Classified |
| Reason | C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual |
| Root cause | Device Design |
| Action | Hologic issued Urgent Medical Device Correction Letter customized to the customer on 01/16/23. Letter states reason for recall, health risk and action to take: We will schedule a service appointment and dispatch a field service engineer to visit your site to inspect your system and if necessary, make any corrections. " This will take approximately 6-14 hours to complete. " Until your service appointment, you will be able to continue to use your Selenia Dimensions or 3Dimensions system. If at any time during system operation, you observe any unanticipated error messages, or unexpected Carm move |
| Quantity | 797 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.