FDA Recall
Terminated
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.
Recall: Z-1854-2021
·
Initiated May 5, 2021
Recall
- Recall Number
- Z-1854-2021
- Event Number
- 87904
- Firm
- Abbott Laboratories Inc. (St Jude Medical)
- FEI Number
- 1000139754
- Product Code
- DQK
- Status
- Terminated
- Root Cause
- Software Manufacturing/Software Deployment
- Initiated
- May 5, 2021
- Terminated
- June 18, 2024
- Address
- 1 Saint Jude Medical Dr, Saint Paul, MN, 55117-1789
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
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Action
Beginning on May 5, 2021, consignees will be notified in person by an Abbott field representative. The letter explained the issue and provided recommendations to reduce the risk to the patient.
Distribution
US Nationwide distribution in the states of MI, KS, MO, TX.
Quantity
9 units