Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).
- Recall Initiated
- April 7, 2020
- Terminated
- January 22, 2021
- Recall Number
- Z-1935-2020
- Quantity
- 34 units
- Firm Location
- Portage, MI
Reason for Recall
Ambulance Cots may not meet crash test standard BS EN 1789
Distribution
Foreign: UK
Lot / Code Info
Serial Numbers: 1909003700051 1909003700052 1909003700055 1909003700056 1909003700057 1909003700058 1909003700059 1909003700060 1909003700061 1909003700062 1909003700065 1909003700066 1909003700067 1909003700068 1909003700069 1909003700070 1909003700072 1909003700073 1909003700074 1909003700075 1909003700076 1909003700077 1909003700078 1909003700079 1909003700080 1909003700081 1909003700082 1909003700083 1909003700084 1909003700085 1909003700086 1909003700087 1909003700088 1909003700090
Root Cause
Component change control
Action Taken
Stryker issued Initial notification to International distribution partners via electronic notification system on 4/7/20. Customers will be notified by written letter distributed via traceable methods. Letter states reason for recall, health risk and action to take: 1. Locate the units listed on the attached business reply form and identify the address where they can be serviced. 2. Return the enclosed business reply form to confirm receipt of this notification by fax or email 269 488 8691 or email productfieldaction@stryker.com the enclosed acknowledgement of this notification. Power-PRO" TL cot crash test standard Model: 6550 GTIN: 07613327261660 Month dd, yyyy Attn: Recall Coordinator/ Fleet Manager URGENT: URGENT: MEDICAL DEVICE MEDICAL DEVICE MEDICAL DEVICE MEDICAL DEVICE CORRECTIONCORRECTIONCORRECTION CORRECTION CORRECTIONCORRECTION Model numbers Product description Serial number(s) 6550-000-000 Power-PRO" TL cot manufactured between Sept 9, 2019 and Nov 7, 2019 See Attachment Pg. 2 3. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the modification/repair of your Power-PRO " TL cot. 4. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 5. If you have disposed of any of these units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form. If you have any questions or concerns, please contact Customer Service +1 800 327 0770. Our normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).