Reported Jun 23, 2021 · Terminated
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a…
Abbott Laboratories Inc. (St Jude Medical)
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: Abbott Laboratories Inc. (St Jude Medical) · 1 Saint Jude Medical Dr · Saint Paul, MN · 55117-1789
Is this the product you have?
- v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
- Lot codes and dates
- Serial Numbers
14399319155089621878271218855856
- Serial Numbers
- Amount recalled
- 4 units
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
Why it was recalled
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
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.
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