Class 2 Device Recall Stryker Epic II critical care bed

• Date Initiated by Firm: August 10, 2009
• Date Posted: September 18, 2009
• Recall Status: Terminated on April 25, 2011
• Recall Number: Z-2213-2009
• Recall Event ID: 52230
• Product Classification: Bed, ac-powered adjustable hospital - Product Code FNL
• Product: Stryker Epic II critical care bed, 115v, Stryker Medical, Portage, MI; Model 2030.; ; Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.
• Code Information: Note these serial numbers are inclusive for models 2030 and 2031. 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• Recalling Firm/ Manufacturer: Stryker Medical Div. of Stryker Corporation; 3800 E. Centre Ave.; Portage MI 49002
• For Additional Information Contact: 269-324-6527
• Manufacturer Reason for Recall: The backrest of the bed may not stay in an upright position (may drift down when left raised).
• FDA Determined Cause: Device Design
• Action: Stryker Medical issued an "Urgent - Medical Device Correction" letter dated August 10, 2009 informing customers to locate the affected product listed and verify whether it is functioning properly. In the case the device is not properly functioning, remove from service and contact the firm as soon as possible at 1-800-STRYKER, option 3. Customers are also asked to return an enclosed return receipt post card and also forward the notification to users who have loaned or purchased the device. A representative from Stryker field service will be contacting you to perform device corrections shortly. For further information, contact Stryker Medical at 1-269-324-6527.
• Quantity in Commerce: 12,599 total products
• Distribution: Worldwide Distribution -- United States, Brazil, Canada, Chile, China, India, Korea, Latin America, Mexico, Singapore and Switzerland.
• 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.