FDA Device recall Z-0802-2019
ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
- FDA Device
- Class II
- terminated
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class II recall of ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800 by Arjohuntleigh Magog, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0802-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-19 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Arjohuntleigh Magog |
| Distribution | n/a |
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.
Identifiers
| code_info | All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0802-2019%22
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