Z-3004-2026 Class II Ongoing
FDA device recall Z-3004-2026 was initiated by Merge Healthcare, Inc. on July 22, 2026 and is designated Class II. Reason for recall: Software issue may cause measurements to be displayed inaccurately. The recall status is ongoing. Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2026
- Initiation Date
- July 22, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Reason for Recall
Software issue may cause measurements to be displayed inaccurately.
Distribution Pattern
US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
Code Information
Software version V9.5 - UDI (01)00842000101239(10)9.5.0(11)260409