Abbott Laboratories Inc. (St Jude Medical) 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Abbott Laboratories Inc. (St Jude Medical)
Lot Codes / Batch Numbers
Serial Numbers: 14399319, 15508962, 18782712, 18855856
Products Sold
Serial Numbers: 14399319, 15508962, 18782712, 18855856
Abbott Laboratories Inc. (St Jude Medical) is recalling v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate due to Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026