Class 2 Device Recall PowerPRO XT, PowerPRO IT, PowerPRO TL

• Date Initiated by Firm: May 05, 2016
• Create Date: June 14, 2016
• Recall Status: Terminated on September 18, 2017
• Recall Number: Z-1990-2016
• Recall Event ID: 74207
• Product Classification: Stretcher, wheeled - Product Code FPO
• Product: 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.
• Code Information: Model numbers: 6506-000-000, 6516-000-000, 6550-000-000 Serial Numbers 150740131 150740132 150740133 150740134 150740135 150740136 150740137 150740138 150740289 150740290 150740291 150740292 150740293 150740294 150740295 150740296 150740297 150740298 150740299 150740550 150740551 150740552 150740553 150740554 150740555 150740556 150740557 150740558 150740559 150740560 150740561 150740562 150740563 150740564 150740565 150740566 150740567 150740568 150740569 150740570 150740587 150740588 150740589 150740590 150740591 150740592 150839490 150840425 150840426 150840427 150840428 150840429 150840430 150840431 150840432 150840433 150840434 150840435 150840436 150840437 150840438 150840439 150840440 150840441 150840442 150840443 150840444 150840445 150840446 150840447 150840448 150840449 150840450 150840493 150840495 150840496 150840497 150840498 150840499 150840550 150840551 150840552 150840553 150840554 150840555 150840556 150840557 150840558 150840559 150840560 150840561 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• Recalling Firm/ Manufacturer: Stryker Medical Division of Stryker Corporation; 3800 E Centre Ave; Portage MI 49002-5826
• For Additional Information Contact: Stryker Customer Service; 800-327-0770
• Manufacturer 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
• FDA Determined 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 in Commerce: 770
• Distribution: Distributed US (nationwide) and the countries of Australia, Canada, Hong Kong, Spain, Switzerland, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.