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Class 2 Device Recall Medical Surgical Bed, Model 3005S3EX |
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Date Initiated by Firm |
December 18, 2012 |
Date Posted |
January 03, 2013 |
Recall Status1 |
Terminated 3 on August 30, 2013 |
Recall Number |
Z-0629-2013 |
Recall Event ID |
63602 |
Product Classification |
Bed, ac-powered adjustable hospital - Product Code FNL
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Product |
Medical Surgical Bed, Model 3005S3EX
Medical Surgical Bed The S3" MedSurg Bed, Model 3005 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 3005S3EX, Serial Number 120415087 - 120515468, |
Recalling Firm/ Manufacturer |
Stryker Medical Division of Stryker Corporation 3800 East Centre Ave. Portage MI 49002
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For Additional Information Contact |
Blaine Burnette 269-488-8691
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Manufacturer Reason for Recall |
Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes.
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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 |
1004 |
Distribution |
Worldwide Distribution - Nationwide and Canada |
Total Product Life Cycle |
TPLC Device Report
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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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