v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, 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.
Reported: June 23, 2021 Initiated: May 5, 2021 #Z-1854-2021
Product Description
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, 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.
Reason for Recall
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Details
- Recalling Firm
- Abbott Laboratories Inc. (St Jude Medical)
- Units Affected
- 9 units
- Distribution
- US Nationwide distribution in the states of MI, KS, MO, TX.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, 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.. Recalled by Abbott Laboratories Inc. (St Jude Medical). Units affected: 9 units.
Why was this product recalled? ▼
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 23, 2021. Severity: Moderate. Recall number: Z-1854-2021.
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