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Recall Observatory FDA recall evidence

Device product

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).

Z-1935-2020

April 07, 2020

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 85549
Status
Terminated
Classification
Class II
Quantity
34 units
Official record key
device-enforcement:Z-1935-2020

Official wording

Reason: Ambulance Cots may not meet crash test standard BS EN 1789

Code information: 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

Distribution pattern: Foreign: UK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ambulance Cots may not meet crash test standard BS EN 1789