v — Class II medical device recall Z-1853-2021
Terminated recall by Abbott Laboratories Inc. (St Jude Medical), reported 2021-06-23, distributed nationwide. Due to a software error, the user may lose functionality of the system or the screen may turn black during ope
| Recall number | Z-1853-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories Inc. (St Jude Medical), Saint Paul, MN, United States |
| Recall initiated | 2021-05-05 |
| Classified | 2021-06-14 |
| Reported by FDA | 2021-06-23 |
| Terminated | 2024-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| Reason classes | software |
| Serial numbers | 14399319, 15508962, 18782712, 18855856 |
| Model numbers | H700123 |
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.
Reason for recall
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1853-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.