Reported Aug 24, 2016 · Terminated
iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images,…
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?
- iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
- Lot codes and dates
- iConnect Access V4.0 or earlier with any version of Ortho PACS and iConnect Access V4.1 with Ortho PACS V5.1.2 and earlier.
- Amount recalled
- 146 sites may have the affected version for both products
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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