FDA Device recall Z-1854-2021
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-b…
- FDA Device
- Class II
- terminated
- Published 2021-06-23
On 2021-06-23 the FDA classified a Class II recall of 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-b… by Abbott Laboratories St Jude Medical, citing due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1854-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-05 |
| Published | 2021-06-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Laboratories St Jude Medical |
| Distribution | US |
Product
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.
Reason
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Identifiers
| code_info | Serial Numbers: 14774202, 14779111, 15812169, 15812170, 18243196, 18243205, 18643643, 18782716, 18917926 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1854-2021%22
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