| Class 2 Device Recall Stryker inTouch Zoom Critical Care | |
Date Initiated by Firm | November 02, 2007 |
Date Posted | December 08, 2007 |
Recall Status1 |
Terminated 3 on October 27, 2010 |
Recall Number | Z-0357-2008 |
Recall Event ID |
45445 |
Product Classification |
Hospital Bed - Product Code FNL
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Product | Stryker inTouch Zoom Critical Care bed, Model 2140, Stryker Medical, Portage, MI 49002 |
Code Information |
All units. (Model Number 2140/Serial Numbers: T01121, T01205, T01350, T01213 thru T01214, T01224, T01014 thru T01036, T01143, T01227, T01211, T01379 thru T01383, T01202, T01053 thru T01099. T01100 thru T01144, T01159, T01179, T01182, T01378, T01186, T01201, T01212, T01057, T01060,T01079,T01200, T01183, T01189, T01223, T01209, T01218, T01172, T01188, T01058, T01171, T01173, T01195, T01203, T01206, T01210, T01216, T01217, T01228, T01176, T01185, TO1193, T01207, T01225, T01215, T01229, T01187, T01311 thru T01320, T01230, T01175, T01180, T01190, T01196, T01037 thru T01052, T01198, T01184, T01192, T01177, T01194, T01204, T01219, T01199, T01191, T01226, T01181, T01197, T01222, T01231 thru T01308,T01208, T01349, T01221, QT01001 thru QT01012, QT01169 and QT01170) |
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 |
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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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