FDA Enforcement
Class II
Terminated
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Recall: Z-1855-2021
·
Reported June 23, 2021
Enforcement
- Recall Number
- Z-1855-2021
- Event ID
- 87904
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Abbott Laboratories Inc. (St Jude Medical)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- June 23, 2021
- Initiation Date
- May 5, 2021
- Classification Date
- June 14, 2021
- Termination Date
- June 18, 2024
- Address
- 1 Saint Jude Medical Dr, Saint Paul, MN, 55117-1789, United States
Description
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Reason
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Code Info
None
Distribution
US Nationwide distribution in the states of MI, KS, MO, TX.
Quantity
8 units