Official recall notice
FDA DeviceClass IINotable
FDA Recall: Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
- Recall date
- 2026-09-02
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Software issue may cause measurements to be displayed inaccurately.
Product description
Software issue may cause measurements to be displayed inaccurately.
Affected products
Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409