FDA recall, , Moderate risk
FUJIFILM Synapse PACS Software
The software may cause the ruler measurement to be inaccurate.
Summary by Recall Canary from the FDA notice
What happened
Fujifilm Healthcare Americas Corporation of Lexington, Massachusetts, began a recall of Fujifilm Synapse PACS software v7.4.310, a radiological image processing system, on July 22, 2026, because a software issue may cause the ruler measurement to be inaccurate.
The recall was added to the FDA's Enforcement Report on August 26, 2026, and was included in the FDA's weekly enforcement report on September 2, 2026. The product was distributed in the states of New York, Virginia, Kansas, Oregon, and Ohio, and in Australia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
- UDI-DI
- 00854904006008
- 00272120
- 0080080176
- 01318490
- 80102732
- 80057523
- 00494020
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of New York, Virginia, Kansas, Oregon, Ohio, and the country of Australia.
- Company
- FUJIFILM Healthcare Americas CorporationLexington, Massachusetts
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99529
- Recall number
- Z-3030-2026
- Quantity recalled
- 6 units
All recalls from FUJIFILM Healthcare Americas Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
