CLASS II Device recall · Reported 28 Oct 2020 · FDA Enforcement Report
Synapse PACS recalled by Fujifilm Medical Systems U.S.A
Fujifilm Medical Systems U.S.A is recalling Synapse PACS, distributed nationwide in the US. The recall was initiated on 11 Sep 2020 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-0282-2021
- FDA event ID
- 86494
- Recalling firm
- Fujifilm Medical Systems U.S.A, Lexington, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Sep 2020
- FDA classified
- 22 Oct 2020
- Reported
- 28 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 11 Sep 2020 | Recall initiated by company | |
| 22 Oct 2020 | Classified by FDA | +41 days |
| 28 Oct 2020 | 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
FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.
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 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
Where it was distributed
US Nationwide distribution including in the state of Minnesota.
Questions about this recall
Is Synapse PACS recalled?
Yes. Fujifilm Medical Systems U.S.A recalled Synapse PACS on 11 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0282-2021.
Why was it recalled?
FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.
Which lots are affected?
Synapse Software Version 5.6.1
Where was it sold?
US Nationwide distribution including in the state of Minnesota.
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 Medical Software recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled | Philips North America | Device Malfunction | MA |
| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |