PlainRecordsFDA · Medical device recall
Arjohuntleigh Getinge Group…
- Date
- Feb. 13, 2019
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Arjohuntleigh Magog
- 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.
- Distribution pattern
- US, Saudi Arabia, and Kuwait
- Quantity
- 231 units
- Codes and lots
- All Serial Numbers
- Recall started
- Dec. 19, 2018
- Device type
- Bed, Patient Rotation, Powered
- Root cause (FDA)
- Component design/selection
- What the company told customers
- Arjo hand-delivered the notice with each RotoProne Therapy System rental and delivery beginning on 12/19/2018. Arjo will require the customer to confirm the notification has been received and understood via the signed delivery notification.
- Recall number
- Z-0802-2019
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement report, recall number Z-0802-2019. The agency record governs; check it and the company before acting.