Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-0811-2024·Announced 2024-01-31

MRI Liquid Cooling Cabinet may have incorrect electrical shock warning label

Some Philips Intera 1.5T MRI systems have an incorrect warning label on the Liquid Cooling Cabinet that fails to properly warn service personnel of electrical shock hazards.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This FDA Class III device recall involves a labeling error related to electrical shock hazards. While electrical shock is a serious potential hazard, no injuries or incidents have been reported, and the issue is primarily an incorrect or missing warning label rather than a defect in the device itself.

Plain-English summary

Affected Philips Intera 1.5T magnetic resonance imaging (MRI) systems may have an incorrect warning label installed on the Liquid Cooling Cabinet (LCC). The warning label has a white background instead of the required yellow, and is missing the high voltage warning symbol.

This incorrect labeling presents a potential risk of electrical shock to service personnel who work on or near the cooling cabinet. The improper warning label may fail to adequately alert technicians to the presence of high-voltage electrical components.

This recall affects 7 units in the United States (distributed in Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska, and Texas) and 16 units in other countries (Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia). Affected systems can be identified by Model No. 781195 with serial numbers 18887 or 18972.

Service personnel and facility administrators should verify that correct warning labels are affixed to the Liquid Cooling Cabinet on affected systems and contact the manufacturer for corrective labeling if needed.

The recalled product

Product: Intera 1.5T, Model No. 781195
Manufacturer: Philips North America
Category: Medical Device
Hazard: electrical-shock
incorrect-labeling
high-voltage-hazard

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 No. 781195 UDI-DI N/A Serial Number 18887 18972

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Philips North America 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 6 products in this recall →

Same manufacturer · Philips North America

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Same hazard · electrical shock