Class 2 Device Recall Flexicair MC3

• Date Initiated by Firm: May 12, 2009
• Date Posted: August 03, 2009
• Recall Status: Terminated on April 03, 2012
• Recall Number: Z-1875-2009
• Recall Event ID: 52032
• 510(K)Number: K863047
• Product Classification: air therapy mattress - Product Code IOQ
• Product: Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.
• Code Information: All serial numbers. The prefix "IC" is representative of a Flexicair¿ MC3 and a six digit number without a prefix is representative of a refurbished Flexicair¿ MC3.
• Recalling Firm/ Manufacturer: Hill-Rom Manufacturing, Inc.; 4349 Corporate Rd; Charleston SC 29405-7445
• For Additional Information Contact: Joe Fogel; 843-740-8586
• Manufacturer Reason for Recall: The devices may emit smoke from the blower box assembly.
• FDA Determined Cause: Equipment maintenance
• Action: Urgent Field Safety Notice letter dated May 11, 2009. Hill-Rom service centers were notified by letter on 05/13/2009. Action to be taken are as follows: Rental Customers; In the next 60 days, Hill Rom will be removing the Flexicair II and Flexicair MC3 low Airloss Therapy Units from service to correct the devices. During that time, Hill-Rom may provide an equivalent substitute therapy to accommodate the patients who continue to need a pressure reducing therapy device. If t his malfunction occurs before a substitution or a corrected device is provided, unplug the device, remove the patient from the surface and notify Hill-Rom immediately. Facility-Owned Customers: In the next 60 days, for all facility owned Flexicair II and Flexicair MC3 Low Airloss Therapy Units, a Hill-Rom service technician will either replace the affected components in the blower assembly or deliver an equivalent substitute unit from Hill-Rom's rental fleet. If this malfunction occurs before the device is corrected or a substitute provided, do as follows: unplug the device, remove the patient from the surface, and immediately notify Hill-Rom Technical Support using the attached listing their geographical region.
• Quantity in Commerce: 889 units
• Distribution: Nationwide and Canada
• 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.

• 510(K) Database: 510(K)s with Product Code = IOQ