Reported Jun 21, 2017 · Terminated
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy…
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 software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
- Lot codes and dates
Versions 7.0.2.17.0.2.27.0.2.37.0.2.3 P1and 7.0.2.3 P2
- Amount recalled
- 47 sites have the potentially affected versions
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Merge Healthcare, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.