Class 2 Device Recall Pressure IQ Evolve Mattress

• Date Initiated by Firm: September 01, 2014
• Date Posted: March 06, 2015
• Recall Status: Terminated on January 04, 2016
• Recall Number: Z-1247-2015
• Recall Event ID: 68235
• Product Classification: Mattress, flotation therapy, non-powered - Product Code IKY
• Product: Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
• Code Information: All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.
• Recalling Firm/ Manufacturer: Arjo Hospital Equipment AB; HANS MICHELSENSGATAN 10; Malm¿ Sweden
• For Additional Information Contact: 210-515-4251
• Manufacturer Reason for Recall: The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
• FDA Determined Cause: Device Design
• Action: On 9/1/14 the recalling firm sent out a letter to their customers notifying them of an updated IFU for the recalled device. The letter also requested the customers to verify the quantity of the product they currently have on hand.
• Quantity in Commerce: 1,034 units
• Distribution: Nationwide Distribution.
• 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.