Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-0807-2024·Announced 2024-01-31

MRI system warning label defect presents electrical shock risk to service personnel

Achieva 1.5T MR systems have incorrect warning labels on the Liquid Cooling Cabinet, missing the high voltage warning symbol. This presents a potential electrical shock risk for 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: This is a Class III labeling defect with a potential electrical hazard, with no reported illnesses or injuries. The missing warning label is a minor labeling error affecting service personnel only, making it moderate rather than high severity.

Plain-English summary

Philips North America is recalling Achieva 1.5T MR (Magnetic Resonance) systems with model numbers 781178, 781196, and 781296. The affected systems have an incorrect electrical shock warning label placed on the Liquid Cooling Cabinet (LCC).

The incorrect label has a white background instead of the proper yellow background, and is missing the high voltage warning symbol. This labeling defect presents a potential risk of electrical shock for service personnel who perform maintenance or repairs on the equipment.

The recall affects a total of 23 units distributed worldwide: 7 in the United States (Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska, and Texas) and 16 in other countries including Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.

If you operate or maintain one of these MR systems, verify that the warning labels on the Liquid Cooling Cabinet are correct, with yellow backgrounds and complete high voltage warning symbols. Contact Philips for corrective measures if your system is affected.

The recalled product

Product: Achieva 1.5T, Model No. 781178, 781196, 781296
Manufacturer: Philips North America
Category: Medical Device — Diagnostic Imaging / MRI
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 (3)

Model No. 781178 UDI-DI N/A Serial Number 20150
Model No. 781196 UDI-DI N/A Serial Nos. 22270 22095 21113
Model No. 781296 UDI-DI 00884838004108 Serial Nos. 33406 33547 32773 32789 32388

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