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Terminated

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.

FDA Recall Z-1990-2016 · Posted None

Recall StatusTerminated
Product CodeFPO
Date Initiated2016-05-05
Date Terminated2017-09-18
Product Quantity770

Reason for Recall

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

Firm 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).

Root Cause

Vendor change control

Distribution Pattern

Distributed US (nationwide) and the countries of Australia, Canada, Hong Kong, Spain, Switzerland, and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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