Agency classClass IIOur severity:High FDA (Devices)·Z-1827-2014·Announced 2014-06-25

Philips MR Trolley Recall for Foot Clamping Hazard

Philips is recalling Height Adjustable FlexTrak trolleys and Trolley Variable Height IRFs for Ingenia MR systems due to a risk of foot clamping.

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 has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Philips Medical Systems, Inc. is recalling the Height Adjustable FlexTrak trolley and Trolley Variable Height IRF, which are optional devices used with Ingenia 1.5T and 3.0T diagnostic MR systems. These devices are designed to prepare patients outside the examination room to enhance workflow.

The recall is being issued because Ingenia customers have experienced clamping of the foot under the central column of the trolley. The affected products are identified by model number 9896 030 1929.1.

The recall covers five units distributed worldwide, including the United States, Canada, Mexico, and numerous countries in Europe, Asia, and the Middle East. Users of these devices should contact Philips Medical Systems for further instructions regarding the recall.

The recalled product

Product: Philips MR systems: Trolley Variable Height IRF (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: 5

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 (1)

Model Number: 9896 030 1929.1

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