CLASS II Device recall · Reported 21 Sep 2016 · FDA Enforcement Report
RadSuite software. The firm name on the label is Merge Healthcare recalled
Merge Healthcare is recalling RadSuite software. The firm name on the label is Merge Healthcare, distributed nationwide in the US. The recall was initiated on 6 May 2013 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-2796-2016
- FDA event ID
- 74815
- Recalling firm
- Merge Healthcare, Hartland, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 May 2013
- FDA classified
- 14 Sep 2016
- Reported
- 21 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 6 May 2013 | Recall initiated by company | |
| 14 Sep 2016 | Classified by FDA | +1227 days |
| 21 Sep 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
Multiple studies were missing at a customer location that never made it to the archive before watermarking
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
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Where it was distributed
Distribution was nationwide to medical facilities. Government distribution was made to LA and OK.
Questions about this recall
Why was it recalled?
Multiple studies were missing at a customer location that never made it to the archive before watermarking
Which lots are affected?
This potential patient safety issue is only present in the following versions when a reverse workflow is used: 2004-R6.x, 5.10.x, 5.20, 5.25, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 8.30.0. NOTE: The standard workflow is not impacted. .
Where was it sold?
Distribution was nationwide to medical facilities. Government distribution was made to LA and OK.
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.
More recalls from Merge Healthcare
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|---|---|---|---|---|---|
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Merge OrthoPACS, medical imaging diagnostic workstation recalled | Merge Healthcare | Other | Nationwide |
| Device | CLASS II | Merge PACS, medical imaging diagnostic workstation recalled | Merge Healthcare | Other | Nationwide |
| Device | CLASS II | The Merge Hemo recalled by Merge Healthcare | Merge Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Vericis, Merge Cardio recalled by Merge Healthcare | Merge Healthcare | Device Malfunction | WI |
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| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |