Recall Z-1990-2016 ยท FPO Stretcher, Wheeled
Stryker Medical Division of Stryker Corporation
Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environments.
| Date | May 5, 2016 |
| Status | Terminated |
| Reason | Complaints of smoke coming from the foot end of the cot. This reportedly occurred when either the battery was placed into the cot or shortly after placing the battery into the cot. In addition to the alleged smoking, one of the reports had also noted that when the user attempted to lower the cot (prior to the alleged smoking) the device went into high speed retract and then a few moments later i |
| Root cause | Vendor change control |
| Action | On 5/5/2016, IMPORTANT MEDICAL DEVICE NOTIFICATION notifications dated 5/3/2016 were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any questions or concerns, please contact Stryker Customer Service (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m-6 p.m. (EST). |
| Quantity | 770 |
| Distribution | Distributed US (nationwide) and the countries of Australia, Canada, Hong Kong, Spain, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.