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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker inTouch Critical Care

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  Class 2 Device Recall Stryker inTouch Critical Care see related information
Date Initiated by Firm November 02, 2007
Date Posted December 08, 2007
Recall Status1 Terminated 3 on October 27, 2010
Recall Number Z-0356-2008
Recall Event ID 45445
Product Classification Hospital Bed - Product Code FNL
Product Stryker inTouch Critical Care bed; Model 2130, Stryker Medical, Portage, MI 49002
Code Information All units (Model Number 2130/Serial Numbers: T01145 thru T01156, T01335 thru T01348 and TO1160 thru T01168)
Recalling Firm/
Manufacturer		 Stryker Medical Div. of Stryker Corporation
3800 E. Centre Ave.
Portage MI 49002
For Additional Information Contact Mike Mazelin
800-669-4968 Ext. 6687
Manufacturer Reason
for Recall		 Multiple defects: 1) beds exhibit reverse motions when the Fowler, gatch or foot section is activated 2) a battery charging defect which may result in a depletion of battery power 3) the touch screen on the footboard freezing, resulting in controls to powered, pressure-relief mattresses being difficult to access 4) beds equipped with zoom drive systems may have an overdrive problem which could re
FDA Determined
Cause 2		 Process control
Action Consignees were notified via an Urgent Medical Device Correction letter dated 11/2/07, and instructed to remove the beds from service if they display any unintended motions and informed that one of the firm's field service representatives will visit the facility to make corrections to all beds under recall.
Quantity in Commerce 329 units total for both models.
Distribution Worldwide-USA 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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