Recall Z-0802-2019— Arjohuntleigh Magog
Class II · Terminated
Class II FDA medical device recall by Arjohuntleigh Magog, initiated 2018-12-19, terminated 2022-01-26. FDA's recall record names no specific 510(k) clearance for this event. Product: ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800. Reason: 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..
- Recalling firm
- Arjohuntleigh Magog
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-19
- Terminated
- 2022-01-26
- Firm location
- Magog, Quebec, Canada
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.