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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Electric Stretcher, Model 1050.

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  Class 2 Device Recall Stryker Electric Stretcher, Model 1050. see related information
Date Initiated by Firm February 27, 2009
Date Posted April 05, 2009
Recall Status1 Terminated 3 on April 25, 2011
Recall Number Z-1230-2009
Recall Event ID 51223
Product Classification Wheeled Hospital Stretcher - Product Code FPO
Product Stryker Electric Stretcher with the Quick Drop CPR option, Model 1050.
Code Information Serial numbers 94113214, 94113215, 94113216, 94113217, 94113218, 94113219, 94113220, 94113221, 94113222, 94113223, 94113224, 94113225, 94113226, 94113227, 94113228, 94113229, 94113230, 94113231, 94113232, 94113233, 94113234, 94083551, 94083552, 94083553, 94083554, 94083555, 94083556, 94083557 A, 94083558, 94113211, 9501031208, 9501031209, 9501031210, 9501031211, 9503032237, 9503032238, 9503032239, and 9503032240.  
Recalling Firm/
Manufacturer		 Stryker Medical Div. of Stryker Corporation
3800 E. Centre Ave.
Portage MI 49002
For Additional Information Contact
800-787-9537
Manufacturer Reason
for Recall		 The head section backrest (fowler) may not raise up, or, if up, may drop suddenly due to wearing out of the actuator threads on the fowler.
FDA Determined
Cause 2		 Device Design
Action Consignees were notified by an Urgent - Medical Device Correction letter dated 2/27/09, advised of the problem and instructed to locate stretchers and verify that there is no grinding noise when activating the fowler electrically. Consignees were also instructed to remove any stretchers with a fowler that was non-operational, or which makes a grinding sound, from service until the firm makes repairs and contact the firm. Stretchers will be corrected within the next four months by a Stryker field service representative. The enclosed post card should be returned to confirm receipt of the notification. The notice should be forwarded to any users that have borrowed or purchased the stretchers and the firm should be notified of their new location. Also, if any of the affected stretchers have been disposed of or are no longer in use, the firm needs to be provided with their serial numbers. Questions or concerns should be directed to Andrea Kuthe at 269-324-6581.
Quantity in Commerce 38
Distribution Worldwide Distribution
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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