Recall Z-1144-2023— Hologic, Inc.
Class II · Ongoing
Class II FDA medical device recall by Hologic, Inc., initiated 2023-01-16. FDA's recall record names no specific 510(k) clearance for this event. 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: C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual.
- Recalling firm
- Hologic, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-01-16
- Firm location
- Danbury, CT, United States
Product 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
Reason for recall
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
Data sourced from openFDA. This site is unofficial and independent of the FDA.