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 transport. 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 (such as oxygen bottles, monitors, and pumps). The intended users of the device are trained professionals, including emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers.
FDA Recall Z-1389-2018 · Posted 2018-05-01
Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusTerminated
Product CodeFPO
Date Initiated2018-03-12
Date Terminated2020-05-12
Product Quantity4724
Reason for Recall
The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
Firm Action
On February 27, 2018, affected customers received an Urgent Medical Device Correction Notification via FedEx notifying them of the issue and potential hazard. For distributed units, the four Floor Plate Attachment Brackets that hold the anchor in place will be replaced in the field by Strykers field service personnel. Customers will be asked to return a business reply form to acknowledge that they have received and understand the notification. For further questions, please call (269) 389-8306.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - USA (nationwide) and to the countries of : Australia, Canada, France, Germany, Hong Kong, Italy, India, Netherlands, Portugal, Saint Martin, Switzerland, United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.