RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reported: September 21, 2016 Initiated: May 6, 2013 #Z-2796-2016
Product Description
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason for Recall
Multiple studies were missing at a customer location that never made it to the archive before watermarking
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 45 sites potentially have the affected versions
- Distribution
- Distribution was nationwide to medical facilities. Government distribution was made to LA and OK.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.. Recalled by Merge Healthcare, Inc.. Units affected: 45 sites potentially have the affected versions.
Why was this product recalled? ▼
Multiple studies were missing at a customer location that never made it to the archive before watermarking
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2016. Severity: Moderate. Recall number: Z-2796-2016.
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