Recall Z-1853-2021
Abbott Laboratories Inc. (St Jude Medical) · initiated May 5, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial Numbers: 14399319, 15508962, 18782712, 18855856
Reason for recall
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
FDA-determined cause: Software Manufacturing/Software Deployment
Action taken
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.
Details
- Recall number
- Z-1853-2021
- Initiated
- May 5, 2021
- Terminated
- June 18, 2024
- Product code
- DQK – Computer, Diagnostic, Programmable
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of MI, KS, MO, TX.
- Recalling firm
- Abbott Laboratories Inc. (St Jude Medical), Saint Paul, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1854-2021 Class II | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model…Due to a software error, the user may lose functionality of the system or the screen may turn black during… | 05/05/2021Terminated |
| Z-1855-2021 Class II | WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012Due to a software error, the user may lose functionality of the system or the screen may turn black during… | 05/05/2021Terminated |