Agency classClass IIOur severity:High FDA (Devices)·Z-1950-2024·Announced 2024-06-12

Medical device trolley recalled due to oil leak causing slipping hazard

Philips HA FlexTrak II patient transport trolleys may leak hydraulic oil onto the floor when pressed, creating a slip and fall hazard. About 590 units are affected worldwide.

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 is a risk-of-harm product where injury has not been reported, matching the rubric criterion for Score 3. The hydraulic oil leak creates a potential slip and fall hazard in clinical settings, but no illnesses or injuries are documented in the source material.

Plain-English summary

The Philips HA FlexTrak II is a patient transport trolley used to move patients from preparation areas to MR (magnetic resonance) systems in medical facilities. Hydraulic systems in these trolleys may leak oil when the operator presses the hydraulic pedal during patient transport operations.

When hydraulic oil leaks onto the floor, it creates a slip and fall hazard for hospital staff and patients. The slippery surface increases the risk of falls and injuries in healthcare environments where patient safety is critical.

This recall affects approximately 590 HA FlexTrak II units with specific serial numbers. These trolleys have been distributed worldwide, including across the United States, Australia, Europe, Asia, and other regions.

If you operate or maintain an HA FlexTrak II trolley, contact Philips North America LLC for instructions on how to address the oil leak issue. Do not use the device if you observe oil leaking from the hydraulic system.

The recalled product

Product: HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
Manufacturer: Philips North America Llc
Category: Medical Device — Patient Transport
Hazard: oil-leak
slip-hazard
fall-hazard
Affected units: 590

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