Z-1854-2021 Class II Terminated
FDA device recall Z-1854-2021 was initiated by Abbott Laboratories Inc. (St Jude Medical) on May 5, 2021 and is designated Class II. Reason for recall: Due to a software error, the user may lose functionality of the system or the screen may turn black during operation. The recall status is terminated (terminated June 18, 2024). Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 23, 2021
- Initiation Date
- May 5, 2021
- Termination Date
- June 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
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.
Distribution Pattern
US Nationwide distribution in the states of MI, KS, MO, TX.
Code Information
Serial Numbers: 14774202, 14779111, 15812169, 15812170, 18243196, 18243205, 18643643, 18782716, 18917926