Recall Z-2168-2026 ยท OTE Digital Breast Tomosynthesis
Hologic, Inc
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.
| Date | May 12, 2026 (initiated Apr 8, 2026) |
| Status | Open, Classified |
| Reason | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. |
| Root cause | Device Design |
| Action | On April 8, 2026 URGENT FIELD SAFETY NOTICE letters were sent to customers. Customers were informed of implementing an updated recurring maintenance inspection for detecting loosened, missing, or broken bolts within the VTA. Hologic Service will reach out to schedule your service appointment and perform the required inspection. Following the initial inspection, recurring inspections are required to be conducted at least every 6 months to ensure continued safe/proper operation of the system. Future inspections will consist of torque and visual confirmation that all bolts are present and that th |
| Quantity | 14837 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.