Z-3030-2026 Class II Ongoing
FDA device recall Z-3030-2026 was initiated by FUJIFILM Healthcare Americas Corporation on July 22, 2026 and is designated Class II. Reason for recall: Software issue may cause the ruler measurement to be inaccurate. The recall status is ongoing. Affected quantity: 6 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
- 6 units
Product Description
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Reason for Recall
Software issue may cause the ruler measurement to be inaccurate.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Code Information
UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38