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U.S. Department of Health and Human Services

Class 2 Device Recall TriaDyne Proventa Critical Care Therapy System

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  Class 2 Device Recall TriaDyne Proventa Critical Care Therapy System see related information
Date Initiated by Firm December 03, 2014
Date Posted February 27, 2015
Recall Status1 Terminated 3 on October 30, 2015
Recall Number Z-1218-2015
Recall Event ID 69970
Product Classification Bed, patient rotation, powered - Product Code IKZ
Product TriaDyne Proventa Critical Care Therapy System.

The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
Code Information SERIAL NUMBERS: 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Recalling Firm/
Arjo Hospital Equipment AB
Malm¿ Sweden
Manufacturer Reason
for Recall
The recalled devices labeling and instructions for use contain unapproved medical claims.
FDA Determined
Cause 2
Labeling design
Action Devices in the rental fleet will be delivered to the customer with revised documents including the updated information. The customers who purchased the devices will be notified of the recall via letter sent by registered mail. The field correction notice will include a recall letter, response form, and updated labeling.
Quantity in Commerce 567 units
Distribution Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
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.