3dimensions And Selenia Dimensions Systems
Recall Summary Hologic Inc. is recalling 3Dimensions and Selenia Dimensions systems distributed to hospitals, pharmacies, and laboratories in New Zealand. The systems require modification to address a safety or performance issue. This is classified as a Class I recall, which is the most serious type.
- Recalling firm
- Hologic (Australia and New Zealand) Pty Ltd
- Product
- 3Dimensions and Selenia Dimensions systems. [Device]. Model: 3Dimensions™ Mammography System and Selenia Dimensions® Mammography System. Affected: Multiple models
- Reason
- The manufacturer identified that the Vertical Track Assembly (VTA) on 3Dimensions and Selenia Dimensions systems may experience internal bolt failure over time. The VTA contains eight internal bolts that secure the C-Arm to the assembly. In 2022, the manufacturer received a report of unexpected C-Arm movement during non-patient use; investigation confirmed that all eight bolts had sheared, allowing the C-Arm to rotate freely, with no resulting injury. Loose, missing, or broken VTA bolts can increase mechanical stress and may lead to shaking, vibration, or uncommanded C-Arm movement. A...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-04-13
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/827520b1-f1fb-4133-b14e-a394367eb54f