Reported Sep 16, 2020 · Terminated
Merge PACS
Merge Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347
Is this the product you have?
- Merge PACS
- Lot codes and dates
- Unique Device Identifier (UDI)v8.1:
- PACS(01)00842000100805(10)8.1(11)191022
- OrthoPACS(01)00842000100805(10)8.1(11)191022 v81.1:
- PACS(01)00842000100805(10)8.1.1(11)200528
- OrthoPACS(01)00842000100805(10)8.1.1(11)200528 V8.1.2
- PACS(01)00842000100805(10)8.1.2(11)200709
- Amount recalled
- 125 total units
Where it was sold
Why it was recalled
Measurements done on the Merge PACS generated MPR s may have incorrect measurements.
This product could cause temporary or reversible health problems — stop using it.
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