The Recall Desk
HighFDA (Devices)·Z-1389-2018·Announced 2018-04-25

Stryker Power-LOAD Cot Fastening System Recalled for Broken Floor Plates

Stryker is recalling 4,724 Power-LOAD Cot Fastening Systems because the floor plates holding ambulance cot anchors may be broken.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural component (floor plates) that may be broken, posing a risk of harm during patient transport, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling 4,724 units of the Power-LOAD Cot Fastening System, Model #6390. The device is intended to assist with loading and unloading a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport.

The recall is being issued because the power load floor plates, which hold the ambulance cot anchors in place during patient transport, may be broken. The device has a maximum safe working load of 870 lb (395 kg), which includes the weight of the ambulance cot, patient, and equipment attached to the cot.

The affected units were distributed worldwide, including in the United States, Australia, Canada, France, Germany, Hong Kong, Italy, India, Netherlands, Portugal, Saint Martin, Switzerland, and the United Kingdom. The intended users are trained professionals, including emergency medical service and medical care center personnel, as well as medical first responders, service technicians, and installers.

The recalled product

Product
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transpo
Affected units
4,724

Distribution

Distributed nationwide across the United States.