CLASS II Device recall · Reported 9 Jun 2021 · FDA Enforcement Report
Synapse Cardiovascular (Synapse CV) recalled
Fujifilm Medical Systems U.S.A is recalling Synapse Cardiovascular (Synapse CV), distributed nationwide in the US. The recall was initiated on 30 Apr 2021 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-1775-2021
- FDA event ID
- 87938
- Recalling firm
- Fujifilm Medical Systems U.S.A, Lexington, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2021
- FDA classified
- 2 Jun 2021
- Reported
- 9 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 30 Apr 2021 | Recall initiated by company | |
| 2 Jun 2021 | Classified by FDA | +33 days |
| 9 Jun 2021 | 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
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence
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 Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center.
Questions about this recall
Is Synapse Cardiovascular (Synapse CV) recalled?
Yes. Fujifilm Medical Systems U.S.A recalled Synapse Cardiovascular (Synapse CV) on 30 Apr 2021. The recall is Class II and its status is Terminated. Recall number Z-1775-2021.
Why was it recalled?
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence
Which lots are affected?
Software Versions: 6.0 to 6.2.1
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center.
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 | ¿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 |
| Device | CLASS II | Synapse PACS recalled by Fujifilm Medical Systems U.S.A | Fujifilm Medical Systems U.S.A | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |