Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0940-2009

Stryker InTouch 1.0 Critical Care Bed; Model 2130. The device is intended to be used as an Intensive Care...

Stryker Medical / initiated 2009-01-05 / Terminated / root cause: design

Stryker Medical Div. of Stryker Corporation began a recall of Stryker InTouch 1.0 Critical Care Bed; Model 2130. The device is intended to be used as an Intensive Care Unit bed on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0940-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
Stryker InTouch 1.0 Critical Care Bed; Model 2130. The device is intended to be used as an Intensive Care Unit bed.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
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.
Root cause tag
design
FDA root 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.
Product codes and lots
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.