Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36730 |
| Brand Name: | 3Dimensions and Selenia Dimensions systems |
| Model: | 3Dimensions™ Mammography System and Selenia Dimensions® Mammography System |
| Affected: | Multiple models |
| Software version: | |
| Recalling Organisation: | Hologic (Australia and New Zealand) Pty Ltd c/o Logical Freight Solutions NZ Ltd Unit 8/113 Pavilion Drive Airport Oaks Auckland 2022 |
| Contact Information: | |
| Manufacturer: | Hologic Inc |
| Issue: | 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 corrective action was previously implemented, and affected systems were remediated at that time. The manufacturer has determined that the earlier corrective actions required further improvement to ensure adequate risk mitigation, and the scope of impacted systems covered by those actions should be expanded to enhance detection and prevention of VTA bolt related- issues. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/4/2026 |
