CLASS II Device recall · Reported 29 Apr 2020 · FDA Enforcement Report
ClearCanvas RIS/PACS recalled by Synaptive Medical
Synaptive Medical is recalling ClearCanvas RIS/PACS. The recall was initiated on 26 Feb 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-1758-2020
- FDA event ID
- 85216
- Recalling firm
- Synaptive Medical, Toronto, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2020
- FDA classified
- 22 Apr 2020
- Reported
- 29 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 26 Feb 2020 | Recall initiated by company | |
| 22 Apr 2020 | Classified by FDA | +56 days |
| 29 Apr 2020 | 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
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
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
ClearCanvas RIS/PACS
Where it was distributed
US
Questions about this recall
Is ClearCanvas RIS/PACS recalled?
Yes. Synaptive Medical recalled ClearCanvas RIS/PACS on 26 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1758-2020.
Why was it recalled?
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Which lots are affected?
ClearCanvas RIS/PACS, partt number SYN-0524 with versions 3.0 and higher. Unique Device Identifier (UDI)# (01)00670082000115 (10)1x1
Where was it sold?
US
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.
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