Fujifilm Healthcare Americas Corporation: System, Image Processing, Radiological
FUJIFILM Synapse PACS software version 7.4.310, used for processing radiological images, has a software issue that can cause inaccurate measurements when using the ruler tool. This Class II recall affects systems distributed nationwide in the US and in Australia. Healthcare facilities using this software version should contact FUJIFILM Healthcare Americas Corporation for more information.
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Product
- FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
- Reason
- Software issue may cause the ruler measurement to be inaccurate.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-22
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6a3e5e85-1a0b-40c1-81d8-6b5a4de230c0