Recall Z-0234-2008 ยท FPO Stretcher, Wheeled
Stryker Medical Div. of Stryker Corporation
Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1231, Stryker Medical, Portage, MI 49002
| Date | Nov 10, 2007 (initiated Nov 15, 2004) |
| Status | Terminated |
| Reason | 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.