The Recall Desk
HighFDA (Devices)·Z-1948-2024·Announced 2024-06-12

HA FlexTrak Patient Transport Device Oil Leak Poses Slipping Hazard

Oil may leak from the HA FlexTrak patient transport device when the hydraulic pedal is pressed, creating a potential slipping or falling hazard on the floor.

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: This device presents a risk-of-harm product (slipping and falling injury) where no reported illnesses or injuries are stated in the source material, meeting the High severity criterion per the FDA Class II recall rubric.

Plain-English summary

Philips North America LLC is recalling the HA FlexTrak patient transport device (Product Number 989710006411) due to a potential safety hazard.

The HA FlexTrak is used to transport patients from preparation areas to MR (magnetic resonance) imaging systems. When the hydraulic pedal is pressed during operation, oil may leak from the trolley onto the floor, creating a potential slipping or falling hazard for patients and staff.

Approximately 1,348 units have been distributed worldwide, including in the United States and numerous other countries.

Affected facilities should immediately stop using the device and contact Philips North America LLC for repair or replacement instructions.

The recalled product

Product
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
Manufacturer
Philips North America Llc
Hazard
  • oil-leak
  • slipping-hazard
  • fall-risk

Distribution

Distributed nationwide across the United States.