Stryker inTouch Critical Care bed; Model 2130, Stryker Medical, Portage, MI 49002
Stryker Medical Div. of Stryker Corporation began a recall of Stryker inTouch Critical Care bed; Model 2130, Stryker Medical, Portage, MI 49002 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0356-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Medical
- Product
- Stryker inTouch Critical Care bed; Model 2130, Stryker Medical, Portage, MI 49002
- Product code
- FNL Bed, Ac-Powered Adjustable Hospital
- 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
- Root cause tag
- manufacturing process
- FDA root cause
- 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
- Product codes and lots
- All units (Model Number 2130/Serial Numbers: T01145 thru T01156, T01335 thru T01348 and TO1160 thru T01168)
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