Abbott Laboratories Inc. (St Jude Medical) Recall 87904
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.
Abbott Laboratories Inc. (St Jude Medical) Recall 87904 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1854-2021 |
| Event ID | 87904 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of MI, KS, MO, TX. |
| Quantity | 9 units |
| Recall Reason | Due to a software error, the user may lose functionality of the system or the screen may turn black during operation. |
| Device Classification | 20210623 |
| Device Code Info | Serial Numbers: 14774202, 14779111, 15812169, 15812170, 18243196, 18243205, 18643643, 18782716, 18917926 |
| Center Classification Date | 20210614 |
| Recall Initiation Date | 20210505 |
| Recalling Firm | Abbott Laboratories Inc. (St Jude Medical) |
| Initial Notification | Visit |
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