Drug recall
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate…
FDA recall event 87904 · Class II · Abbott Laboratories Inc. (St Jude Medical)
Key facts
| Event ID | 87904 |
|---|---|
| Recall numbers | Z-1853-2021, Z-1854-2021, Z-1855-2021 |
| Recalling firm | Abbott Laboratories Inc. (St Jude Medical) |
| Product type | Devices |
| Products | 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…, 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…, WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a software error, the user may lose functionality of the system or the screen may turn black during operation. |
| Initiation date | May 5, 2021 |
| Report date | Jun 23, 2021 |
| Termination date | Jun 18, 2024 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 1000139754 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: