Device recall
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
- Recall number
- Z-3030-2026
- Event id
- 99529
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Report date
- Sep 2, 2026
- Posted
- Aug 26, 2026
- Initiated
- Jul 22, 2026
- Center classification date
- Aug 26, 2026
- Product code
- LLZ
- Device type
- System, Image Processing, Radiological
- Reason
- Software issue may cause the ruler measurement to be inaccurate.
- Root cause
- Software design
- Quantity
- 6 units
- Code info
- UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K190232
- Location
- Lexington, MA, United States