Recall Z-1854-2021 ยท DQK Computer, Diagnostic, Programmable
Abbott Laboratories Inc. (St Jude Medical)
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.
| Date | May 5, 2021 |
| Status | Terminated |
| Reason | Due to a software error, the user may lose functionality of the system or the screen may turn black during operation. |
| Root cause | Software Manufacturing/Software Deployment |
| 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. |
| Quantity | 9 units |
| Distribution | US Nationwide distribution in the states of MI, KS, MO, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210392 | WorkMate Claris System Abbott, Mar 11, 2021 |