FUJIFILM Synapse PACS software v7.4.310 recall (FUJIFILM Healthcare Americas Corporation)
Medical deviceClass IIOngoing
Summary: FUJIFILM Healthcare Americas Corporation is recalling FUJIFILM Synapse PACS software v7.4.310; radiological image processing system. Reason: Software issue may cause the ruler measurement to be inaccurate.
What is being recalled
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Why
Software issue may cause the ruler measurement to be inaccurate.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia. (states named: Kansas, New York, Ohio, Oregon, Virginia)
How to tell if yours is affected
UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3030-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 22, 2026 |
| Reported | September 2, 2026 |
| Company | FUJIFILM Healthcare Americas Corporation |
| Company location | Lexington, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 6 units |
More recalls from FUJIFILM Healthcare Americas Corporation · all medical device recalls · recalls from July 2026