Class 2 Device Recall Stryker InTouch Critical Care Bed

• Date Initiated by Firm: January 05, 2009
• Date Posted: February 25, 2009
• Recall Status: Terminated on November 05, 2010
• Recall Number: Z-0940-2009
• Recall Event ID: 49610
• Product Classification: ELECTRIC ICU BED; MULTIPLE - Product Code FNL
• Product: Stryker InTouch 1.0 Critical Care Bed; Model 2130.; ; 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
• 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.
• FDA Determined Cause: 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

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.