CLASS II Device recall · Reported 19 Oct 2016 · FDA Enforcement Report
Fujifilm Synapse PACS recalled by Fujifilm Medical Systems U.S.A
Fujifilm Medical Systems U.S.A is recalling Fujifilm Synapse PACS, distributed nationwide in the US. The recall was initiated on 15 Sep 2016 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-0073-2017
- FDA event ID
- 75192
- Recalling firm
- Fujifilm Medical Systems U.S.A, Stamford, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Sep 2016
- FDA classified
- 12 Oct 2016
- Reported
- 19 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 15 Sep 2016 | Recall initiated by company | |
| 12 Oct 2016 | Classified by FDA | +27 days |
| 19 Oct 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Image data for a patients image may not be correct
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
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Where it was distributed
US Nationwide Distribution.
Questions about this recall
Is Fujifilm Synapse PACS recalled?
Yes. Fujifilm Medical Systems U.S.A recalled Fujifilm Synapse PACS on 15 Sep 2016. The recall is Class II and its status is Terminated. Recall number Z-0073-2017.
Why was it recalled?
Image data for a patients image may not be correct
Which lots are affected?
Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx
Where was it sold?
US Nationwide Distribution.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fujifilm Medical Systems U.S.A
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Synapse Cardiovascular (Synapse CV) recalled | Fujifilm Medical Systems U.S.A | Device Malfunction | Nationwide |
| Device | CLASS II | ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit recalled | Fujifilm Medical Systems U.S.A | Device Malfunction | 6 states |
| Device | CLASS II | Synapse PACS - Radiological Image Processing System recalled | Fujifilm Medical Systems U.S.A | Device Malfunction | Nationwide |
| Device | CLASS II | Fujifilm Synapse Pacs recalled by Fujifilm Medical Systems U.S.A | Fujifilm Medical Systems U.S.A | Device Malfunction | Nationwide |
| Device | CLASS III | Wako Hdl-c/Ldl-c Calibrator recalled by Fujifilm Medical Systems U.S.A | Fujifilm Medical Systems U.S.A | Other | Nationwide |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |