Z-0230-2008
Stryker M-series powered patient transport stretcher, Model 1025 (SM304), Stryker Medical, Portage, MI 49002
Stryker Medical / initiated 2004-11-15 / Terminated
Stryker Medical Div. of Stryker Corporation began a recall of Stryker M-series powered patient transport stretcher, Model 1025 (SM304), Stryker Medical, Portage, MI 49002 on . The reason FDA records is "The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0230-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Medical
- Product
- Stryker M-series powered patient transport stretcher, Model 1025 (SM304), Stryker Medical, Portage, MI 49002
- Product code
- FPO Stretcher, Wheeled
- Reason for recall
- The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.
- FDA root cause
- Component change control
- Action
- The firm issued an Urgent Medical Device Correction Letter dated 9/24/07, to each consignee informing them of the problems, that the brakes on each affected stretcher needed to be inspected/tested and removed from service if brake problems were discovered, and that a Stryker service representative would be in contact to replace the brakes.
- Quantity in commerce
- 81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models.
- Distribution
- Worldwide-USA, Argentina, Australia, Brazil, Canada, Chile, China, Dubai, France, India, Italy, Japan, Germany, Greece, Hong Kong, Korea, Latin America, Malaysia, Mexico, Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.
- Product codes and lots
- All stretchers with serial numbers beginning with 0309 through 0505.
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