Recall Z-0737-2008 ยท FPO Stretcher, Wheeled
Sechrist Industries Inc
Sechrist Hyperbaric Chamber Gurney, Standard Gurney Without Siderails & Stretcher Model, P/N 21487, Sechrist Industries, Inc., Anaheim, CA
| Date | Jan 18, 2008 (initiated Oct 31, 2007) |
| Status | Terminated |
| Reason | Brake Problems: The stretcher brake cams may crack while attempting to lock the stretcher brake (Sechrist is supplied the stretchers by the manufacturer Stryker Medical) |
| Root cause | Device Design |
| Action | Urgent Medical Device Correction letters were sent to customers beginning on November 9, 2007, via FedEx & DHL overnight. Customers were notified this action was being taken to providing notification to their customers as a continued implementation of the Stryker Medical field correction. The Notification letter instructed their customers to: 1. Locate the gurneys with the serial numbers listed in this advisory. 2. If any of the affected gurneys cannot be located, determine if they have been sold, transferred, or donated to another facility and notify us regarding their new location. 3. Verif |
| Quantity | 559 Units Total (483 in US) for all models |
| Distribution | Worldwide-USA, Brazil, Bulgaria, Canada, Dubai, U.A.E., Estonia, India, Indonesia, Japan, Malaysia, Saudi Arabia, Sweden, Taiwan, Thailand, and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.