| Class 2 Device Recall Stryker InTouch Critical Care Bed | |
Date Initiated by Firm | January 05, 2009 |
Date Posted | February 25, 2009 |
Recall Status1 |
Terminated 3 on November 05, 2010 |
Recall Number | Z-0942-2009 |
Recall Event ID |
49610 |
Product Classification |
ELECTRIC ICU BED; MULTIPLE - Product Code FNL
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Product | Stryker InTouch 1.0 Critical Care Bed (Model 2130) with the Integrated PositionPro mattress (Model 2920) option.
The device is intended to be used as an Intensive Care Unit bed. |
Code Information |
Serial Numbers: T02152, T02196, T02197, T02198, T02199, T02200, T02201, T02202, T02203, T02204, T02205, T02206, T02207, T02208, T02209, T02210, T02211, T02212, T02213, T02214, T02215, T02216, T02217, T02218, T02219, T02220, T02221, T02222, T02223, T02224, T02225, T02226, T02227, T02228, T02229, T02230, T02231, T02232, T02233, T02234, T02235, T02236, T02237, T01905, T01906, T01907, T01908, T01909, T01910, T01911, T01912, T01913, T01914, T01915, T01916, T01917, T01918, T01919, T01920, T01921, T01922, T01923, T01924, T01925, T01926, T01927, T01928, T01929, T01930, T01931, T01699, T01948, T01949, T01950, T01951, T01952, T01953, T01954, T01955, T01956, T01957, T01958, T01959, T01960, T01961, T01962, T01963, T01964, T01965, T01966, T01967, T01682, T01683, T01684, T01685, T01686, T01687, T01688, T01689, T01543, T01608, T01609, T01718, T01719, T01720, T02075, T02076, T02077, T02239, T02174, T01310, T01721, T01722, T01723, T02011, T02012, T02013, T02014, T02015, T02016, T02058, T02059, T02060, T02061, T02062, T02063, T02064, T02065, T01335, T01336, T01337, T01338, T01339, T01340, T01341, T01342, T01343, T01344, T01345, T01346, T01347, T01348, T01321, T01322, T01323, T01324, T01325, T01326, T01327, T01328, T01329, T01330, T01331, T01332, T01610, T01611, T01612, T01613, T02513, T02514, T02515, T01661, T01662, T01663, T01664, T01665, T01525, T01526, T01384, T01385, T01386, T01387, T01388, T02506, T02507, T02508, T02509, T02510, T02511, T02512, T02066, T02067, T02068, T01370, T01371, T01372, T01373, T01374, T01375, T01376, T01377, T01572, T01368, T01369, T02166, T02167, T02168, T02169, T02170, T02171, T02172, T02173, T01156, T01547, T01548, T01696, T01552, T01553, T01554, T01555, T02175, T02176, T02177, T02178, T02179, T02180, T02090, T02088, T01546, T01544, T02087, T01698, T02089, T01551, T01697, T01545, T01550 and T01695. |
Recalling Firm/ Manufacturer |
Stryker Medical Div. of Stryker Corporation 3800 E. Centre Ave. Portage MI 49002
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For Additional Information Contact | 269-324-6644 |
Manufacturer Reason for Recall | The touch screen on the footboard may display a "tilt over range" error, resulting in a precautionary stop of the bed motions which result in the bed appearing to have locked out some of its bed positioning features. Also, the "hold" button, used to interrupt an intended patient turn on beds with an integrated PositionPro mattress, may only function intermittently, resulting in an inability to ho |
FDA Determined Cause 2 | Device Design |
Action | Consignees were notified of the problems via letter dated January 5, 2009, advised to check their beds and to take them out of service if the foot board touchscreen displayed a "tilt over range" error, and that a Stryker Medical field service representative would contact them to perform software upgrades on the affected beds. Please direct questions to Stryker Medical at 1-269-324-6644. |
Quantity in Commerce | 1,288 of all models |
Distribution | Worldwide Distribution including USA and countries of Canada, Japan and Switzerland. |
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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