High FDA (Devices)·Z-1949-2024·Announced 2024-06-12

Medical device recall: HA FlexTrak patient transport trolley oil leak hazard

Philips is recalling the HA FlexTrak patient transport trolley due to potential oil leaks from the hydraulic system that create slipping and falling hazards. Approximately 100 units have been distributed worldwide.

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 is an FDA Class II recall for a medical device with a documented mechanical hazard (hydraulic oil leakage) creating potential slipping and falling hazards. Consistent with the severity rubric for risk-of-harm products where injury has not been reported, this warrants a High severity rating.

Plain-English summary

Philips North America LLC is recalling the HA FlexTrak patient transport trolley (Product Number 989710006412), which is used to transport patients from the preparation area to magnetic resonance systems. Approximately 100 units have been distributed worldwide to healthcare facilities in the United States and over 40 other countries.

Oil may leak from the trolley when the hydraulic pedal is pressed. This leakage creates a potential slipping and falling hazard on the floor.

The FDA has identified specific serial numbers affected by this recall. The complete list of affected serial numbers and additional details are available in FDA recall notice Z-1949-2024.

The recalled product

Product: HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
Manufacturer: Philips North America Llc
Category: Medical Device — Patient Transport Equipment
Hazard: oil-leak
slip-fall-hazard
Affected units: 100

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.

See all 3 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · oil leak