Agency classClass IIOur severity:High FDA (Devices)·Z-1826-2014·Announced 2014-06-25

Philips Ingenia FlexTrak Trolley Recalled for Foot Clamping Hazard

Philips is recalling Ingenia HA FLEX TRAK Trolleys because the central column can clamp a patient's foot. The recall covers 420 units distributed 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: The recall involves a risk-of-harm product where injury (foot clamping) has been reported, but the source does not specify the severity of the injury or mention hospitalizations, fitting the 'High' severity criteria.

Plain-English summary

Philips Medical Systems, Inc. is recalling the Ingenia HA FLEX TRAK Trolley and Trolley Variable Height IRF, which are optional devices used with Ingenia 1.5T and 3.0T diagnostic MR systems. The recall involves 420 units distributed in the United States and internationally.

The recall is being issued because customers have reported that the central column of the trolley can clamp a patient's foot. This device is designed to prepare patients outside the examination room to enhance workflow.

Healthcare facilities should stop using the affected trolleys and contact Philips Medical Systems for further instructions on the recall.

The recalled product

Product: Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room…
Manufacturer: Philips Medical Systems, Inc.
Category: Medical Device — Diagnostic Imaging
Hazard: crush-injury
Affected units: 420

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Model Numbers: 9896 030 1929.2
9896 030 1929.3

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Philips Medical Systems, Inc. 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 2 products in this recall →

Same manufacturer · Philips Medical Systems, Inc.

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Same hazard · crush injury