Class 2 Device Recall RotoProne Therapy System

• Date Initiated by Firm: December 19, 2018
• Date Posted: February 05, 2019
• Recall Status: Terminated 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
• FEI Number: 3002655016
• 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: 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.