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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Stryker Medical Epic II Critical Care Bed with Zoom Drive System; Model 2040. see related information
Date Initiated by Firm February 01, 2008
Date Posted September 19, 2008
Recall Status1 Terminated 3 on November 05, 2010
Recall Number Z-1688-2008
Recall Event ID 45908
Product Classification hospital bed - Product Code FNL
Product Stryker Medical Secure II Med/Surg Bed, 230 V, Stryker Medical, Portage, MI.; Model 3221 (not sold in the U.S.).
Code Information Serial numbers 040915077 through 071116347.
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 2		 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.
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