FDAClass IIFebruary 13, 2019

Arjohuntleigh Getinge Group recall

ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

Why was Arjohuntleigh Getinge Group 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Serial Numbers

Product
ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
Recalling firm
Arjohuntleigh Magog
Quantity
231 units
Distribution
US, Saudi Arabia, and Kuwait
Recall date
February 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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