Merge OrthoPACS workstation recalled for possible image display error
Merge Healthcare's OrthoPACS medical imaging workstation may show thumbnails from a previously opened patient study while a different patient study is open. The recall covers 5 units distributed in the US, Canada and the UK. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check whether your OrthoPACS software is version 9.4, 9.4 P01 or 9.4 P02, with UDI/DI 00842000101154.
- Contact Merge Healthcare for guidance on the affected versions. The notice does not specify a remedy.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Merge OrthoPACS, medical imaging diagnostic workstation
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 5 units
- Illnesses reported
- None reported
- Manufactured in
- 900 Walnut Ridge Dr, Hartland, WI, United States
- Classification
- Class II
- Recall number
- Z-2875-2026
In the FDA's words
- Description
- Merge OrthoPACS, medical imaging diagnostic workstation Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open. UDI/DI (01)00842000101154(10)9.4.0.P02(11)260302, with Affected Versions: 9.4, 9.4 P01, and 9.4 P02. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, and UK. Affected quantity: 5 units
- Hazard
- Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
2 products in this recall
Merge PACS and OrthoPACS workstations recalled for thumbnail display risk
Merge Healthcare is recalling 58 imaging workstations in two products: 53 units of Merge PACS and 5 units of Merge OrthoPACS. Thumbnails from a previously opened patient study may appear in the Thumbnail Bar while a different patient study is open. The FDA classified the recall as Class II. The notice reports no injuries. It covers US nationwide distribution and Canada and the UK.
The agency lists each product separately. Check every one you might have.
- Merge PACS, medical imaging diagnostic workstationZ-2874-2026 · 53 units
- Merge OrthoPACS, medical imaging diagnostic workstation (this page)Z-2875-2026 · 5 units