RecallRadar

FDA Device recall Z-0802-2019

ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

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

AgencyFDA Device
Recall numberZ-0802-2019
ClassificationClass II
Statusterminated
Initiated2018-12-19
Published2019-02-13
Last updated2026-09-13 11:55 UTC
CompanyArjohuntleigh Magog
Distributionn/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_infoAll 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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.