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U.S. Department of Health and Human Services

Class 2 Device Recall Medical Surgical Bed, Model 3002SEX

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  Class 2 Device Recall Medical Surgical Bed, Model 3002SEX see related information
Date Initiated by Firm December 18, 2012
Date Posted January 03, 2013
Recall Status1 Terminated 3 on August 30, 2013
Recall Number Z-0628-2013
Recall Event ID 63602
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product Medical Surgical Bed, Model 3002SEX

Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls
Code Information Model 3002SEX, Serial Number 120315371-120315379
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 East Centre Ave.
Portage MI 49002
For Additional Information Contact Blaine Burnette
269-488-8691
Manufacturer Reason
for Recall		 Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. The affected beds may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes.
FDA Determined
Cause 2		 Process control
Action Stryker sent an Urgent Medical Device Correction letterdated December 18, 2012, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate the affected product and ensure that the brakes are holding properly. Consignees were directed to contact Stryker (1-800-327-0770, option 2) to make arrangements to replace all brake rings and continue to routinely inspect brake functionality. Customers were asked to Fax (269-488-8691) the enclosed acknowledgment and Stryker field service will contact customers to schedule service. Consignees were directed to forward a copy of this notice to the new users and advise us of their new location. For questions regarding this recall call 269-488-8691.
Quantity in Commerce 9
Distribution Worldwide 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.
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