Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D… — Class II medical device recall Z-1144-2023
Ongoing recall by Hologic, Inc., reported 2023-03-01, distributed nationwide. C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
| Recall number | Z-1144-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc., Danbury, CT, United States |
| Recall initiated | 2023-01-16 |
| Classified | 2023-02-21 |
| Reported by FDA | 2023-03-01 |
| Distributed | Nationwide (US) |
| Quantity | 797 units |
| UPC / GTIN / UDI-DI | 15420045505636, 15420045508019 |
| Serial numbers | 3DM160100109, 3DM160100110, 3DM160100112, 3DM160100115, 3DM160100118, 3DM160100122, 3DM160100124, 3DM160100137, 3DM160100138, 3DM160100140, 3DM160100142, 3DM160100149, 3DM160100150, 3DM160100159, 3DM160100160, 3DM160100163, 3DM160100164, 3DM160100166, 3DM160100170, 3DM160100176, 3DM160100179, 3DM160100183, 3DM160100192, 3DM160100230, 3DM160100262 and 475 more |
| Model numbers | 3DM-SYS-STD, 3DM-SYS-STD-NS, RM-SDM-00001-3D, SDA-SYS-3000-2D, SDA-SYS-3000-3D, SDA-SYS-3000-3D-UPS, SDM-00001, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-SYS-6000-3D-HTC, SDM-SYS-9000-2D, SDM-SYS-9000-3D |
Product
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
Reason for recall
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1144-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.