FDA-Device2019-02-13Class II
ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
Arjohuntleigh Magog
Hazard
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.
Sold states
US, Saudi Arabia, and Kuwait
Affected count
231 units
Manufactured in
2001 Rue Tanguay, Magog, Quebec, Canada
Products
ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0802-2019Don't want to check this manually?
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