CLASS II Device recall · Reported 13 Feb 2019 · FDA Enforcement Report

Arjohuntleigh Getinge Group, RotoProne Therapy System recalled

Arjohuntleigh Magog is recalling Arjohuntleigh Getinge Group, RotoProne Therapy System. The recall was initiated on 19 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Serial Numbers

Quantity recalled231 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0802-2019
FDA event ID: 81872
Recalling firm: Arjohuntleigh Magog, Magog, Quebec
Classification: Class II
Status: Terminated
Recall initiated: 19 Dec 2018
FDA classified: 5 Feb 2019
Reported: 13 Feb 2019
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 Dec 2018	Recall initiated by company
5 Feb 2019	Classified by FDA	+48 days
13 Feb 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

Where it was distributed

US, Saudi Arabia, and Kuwait

Questions about this recall

Is Arjohuntleigh Getinge Group, RotoProne Therapy System recalled?

Yes. Arjohuntleigh Magog recalled Arjohuntleigh Getinge Group, RotoProne Therapy System on 19 Dec 2018. The recall is Class II and its status is Terminated. Recall number Z-0802-2019.

Why was it recalled?

Which lots are affected?

All Serial Numbers

Where was it sold?

US, Saudi Arabia, and Kuwait

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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