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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 Systemsee related information
Date Initiated by FirmSeptember 11, 2013
Date PostedFebruary 04, 2014
Recall Status1 Terminated 3 on January 08, 2015
Recall NumberZ-0926-2014
Recall Event ID 67248
Product Classification Bed, patient rotation, powered - Product Code IKZ
ProductThe Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.
Code Information Model #209500
Recalling Firm/
Manufacturer		 ArjoHuntleigh Inc.
4958 Stout Dr
San Antonio TX 78219-4334
For Additional Information Contact
210-515-4251
Manufacturer Reason
for Recall		The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
FDA Determined
Cause 2		Device Design
ActionArjoHuntleigh Inc. sent a Technical Bulletin package to all affected service centers and an Urgent Field Safety Notice package to all affected customers. For rental units, a training plan was established for employees. For sold units, the notice contain a revised user manual and label explaining what to do if the lock pin becomes stuck in the "in" position. Customers that purchased the affected product were required to complete and return a Customer Response form to ArjoHuntleigh to confirm receipt and understanding of the field safety notice, and that the required actions were completed. For questions call 630-785-4885.
Quantity in Commerce231 units
DistributionUS Nationwide and Middle East
Total Product Life CycleTPLC 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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