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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1,348
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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