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.
FDA Recall Z-1853-2021 · Posted None
Recalling FirmAbbott Laboratories Inc. (St Jude Medical)
Recall StatusTerminated
Product CodeDQK
Date Initiated2021-05-05
Date Terminated2024-06-18
Product Quantity4 units
Reason for Recall
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Firm 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.
Root Cause
Software Manufacturing/Software Deployment
Distribution Pattern
US Nationwide distribution in the states of MI, KS, MO, TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.