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U.S. Department of Health and Human Services

Class 2 Device Recall RotoProne Therapy System

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  Class 2 Device Recall RotoProne Therapy System see related information
Date Initiated by Firm December 19, 2018
Date Posted February 05, 2019
Recall Status1 Terminated 3 on January 26, 2022
Recall Number Z-0802-2019
Recall Event ID 81872
Product Classification Bed, patient rotation, powered - Product Code IKZ
Product ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 Arjohuntleigh Magog
2001 Rue Tanguay
Magog Canada Quebec
For Additional Information Contact Field Action Specialist
210-452-1837
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
Action Arjo hand-delivered the notice with each RotoProne Therapy System rental and delivery beginning on 12/19/2018. Arjo will require the customer to confirm the notification has been received and understood via the signed delivery notification.
Quantity in Commerce 231 units
Distribution US, Saudi Arabia, and Kuwait
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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