Class 2 Device Recall Stryker Medical Epic II Critical Care Bed with Zoom Drive System; Model 2040.

• Date Initiated by Firm: February 01, 2008
• Date Posted: September 19, 2008
• Recall Status: Terminated on November 05, 2010
• Recall Number: Z-1689-2008
• Recall Event ID: 45908
• Product Classification: hospital bed - Product Code FNL
• Product: Stryker Medical Epic II Critical Care Bed, 230 V, Stryker Medical, Portage, MI.; Model 2031 (not sold in the U.S.).
• Code Information: Serial numbers 0409060501 through 0711096119.
• Recalling Firm/ Manufacturer: Stryker Medical Div. of Stryker Corporation; 3800 E. Centre Ave.; Portage MI 49002
• For Additional Information Contact: 269-324-6609
• Manufacturer Reason for Recall: The brakes may not have adequate holding power to lock the bed in place.
• FDA Determined Cause: Device Design
• Action: Consignees were notified via letter dated 2/1/08 and informed that upgrade kits along with full written and video installation instructions will be sent to correct the problem.
• Quantity in Commerce: 66,558 of all models.
• Distribution: Worldwide, Argentina, Brazil, Canada, Chile, China, Greece, India Japan, Mexico, Poland, Singapore, South Africa, South Korea, Switzerland, Taiwan and United Kingdom.
• 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.