Reported Feb 13, 2019 · Terminated

ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

Arjohuntleigh Magog

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Arjohuntleigh Magog · 2001 Rue Tanguay · Magog, Quebec · N/A

Is this the product you have?

  • ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
Lot codes and dates
  • All Serial Numbers
Amount recalled
231 units

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 26, 2022 · Data as of Sep 19, 4:49 PM UTC

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