CLASS II ONGOING Device recall · Reported 26 Mar 2025 · FDA Enforcement Report
Synapse PACS recalled by FUJIFILM Healthcare Americas
Fujifilm Healthcare Americas is recalling Synapse PACS, distributed in 30 states. The recall was initiated on 11 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1407-2025
- FDA event ID
- 96360
- Recalling firm
- Fujifilm Healthcare Americas, Lexington, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Feb 2025
- FDA classified
- 20 Mar 2025
- Reported
- 26 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 11 Feb 2025 | Recall initiated by company | |
| 20 Mar 2025 | Classified by FDA | +37 days |
| 26 Mar 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The incorrect computed patient age is showing in VX for patients less than 3 months old.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
Where it was distributed
Domestic: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, OR, TN, TX, VT, WA, WI, WV, WY. International: Australia, Belgium, Brazil, France, Germany, Portugal, UK
ArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIllinoisIndianaKansasKentuckyLouisianaMassachusettsMinnesotaMissouriMississippiNorth CarolinaNew JerseyNew York
Questions about this recall
Why was it recalled?
The incorrect computed patient age is showing in VX for patients less than 3 months old.
Which lots are affected?
Model numbers: Synapse PACS 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200 Software Version Numbers: Synapse PACS 7.4.000, UDI: (01)00854904006008(10)0704000; Synapse PACS 7.4.001, UDI: (01)00854904006008(10)0704001; Synapse PACS 7.4.010, UDI: (01)00854904006008(10)0704010; Synapse PACS 7.4.100, UDI: (01)00854904006008(10)0704100; Synapse PACS 7.4.110, UDI: (01)00854904006008(10)0704110; Synapse PACS 7.4.200, UDI: (01)00854904006008(10)0704200.
Where was it sold?
Domestic: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, OR, TN, TX, VT, WA, WI, WV, WY. International: Australia, Belgium, Brazil, France, Germany, Portugal, UK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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