Arjohuntleigh Magog recalls ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

Recall date

December 19, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0802-2019

FDA classification

Class II

Brand / firm

Arjohuntleigh Magog

Sold / distributed

US, Saudi Arabia, and Kuwait

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800