FDA Medical devices recall ·
FUJIFILM Synapse PACS software v7.4.310 recall
- Recall number
- Z-3030-2026
- Date
- (initiated July 22, 2026)
- Company / brand
- FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300, Lexington, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Why was it recalled?
Software issue may cause the ruler measurement to be inaccurate.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Kansas New York Ohio Oregon Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3030-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.