Recall Z-1854-2021— Abbott Laboratories Inc. (St Jude Medical)
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories Inc. (St Jude Medical), initiated 2021-05-05, terminated 2024-06-18. It names one FDA 510(k) clearance: K210392. Product: 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..
- Recalling firm
- Abbott Laboratories Inc. (St Jude Medical)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-05
- Terminated
- 2024-06-18
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.