Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-0809-2024·Announced 2024-01-31

Philips MRI system recalled for incorrect electrical warning label

Philips Achieva 3.0T MRI systems have an incorrect electrical warning label on the liquid cooling cabinet, missing the high voltage symbol and proper yellow background. This presents a risk of electrical shock to service personnel.

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: FDA Class III recall with no reported illnesses or injuries. The issue is a labeling error affecting electrical safety warnings on high-voltage equipment, which qualifies as a minor labeling defect. The affected population is limited to trained service personnel, not patients or the general public.

Plain-English summary

The Philips Achieva 3.0T MR system (Model No. 781177) is being recalled due to an incorrect electrical shock warning label on the Liquid Cooling Cabinet. The warning label has a white background instead of the required yellow and is missing the high voltage warning symbol.

This labeling error presents a potential risk of electrical shock to service personnel who perform maintenance on these systems. A total of 23 units are affected: 7 in the United States (distributed across Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska, and Texas) and 16 internationally (in Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia).

Affected facilities should contact Philips North America for remediation instructions. Service personnel should exercise appropriate electrical safety precautions when working on the liquid cooling cabinet until the labeling issue is corrected.

The recalled product

Product: Achieva 3.0T, Model No. 781177
Manufacturer: Philips North America
Category: Medical Device — Medical Imaging
Hazard: electrical-shock
missing-warning-label

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. 781177 UDI-DI N/A Serial Number 17043

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