Z-0802-2019 Class II Terminated
FDA device recall Z-0802-2019 was initiated by Arjohuntleigh Magog on December 19, 2018 and is designated Class II. Reason for recall: Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute to a life-threatenin… The recall status is terminated (terminated January 26, 2022). Affected quantity: 231 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2019
- Initiation Date
- December 19, 2018
- Termination Date
- January 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 231 units
Product Description
ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
Reason for Recall
Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute to a life-threatening event.
Distribution Pattern
US, Saudi Arabia, and Kuwait
Code Information
All Serial Numbers