The Recall Desk
ModerateFDA (Devices)·Z-0812-2024·Announced 2024-01-31

MRI Cooling Cabinet Has Incorrect Electrical Warning Label

Cooling cabinets in Philips MRI systems have defective electrical warning labels with incorrect colors and a missing high voltage warning symbol, creating electrical shock risk for service personnel.

What this means for you

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 recall involves a labeling defect with no reported injuries or illnesses. The hazard—electrical shock for service personnel—is theoretical and based on an incorrect warning label, not a product malfunction. Class III recalls are typically scored 1 or 2.

Plain-English summary

Philips North America is recalling SmartPath to dStream MRI systems (Model No. 781260 and 782112) due to defective electrical safety warning labels on the Liquid Cooling Cabinet (LCC) component.

The warning label on the LCC has a caution symbol with a white background instead of the required yellow background. The label is also missing the high voltage warning symbol. These defects prevent service personnel from clearly recognizing electrical shock hazards when performing maintenance and service work.

The recalled units have been distributed in the United States (to facilities in Arkansas, Colorado, Illinois, Maryland, Mississippi, Nebraska, and Texas) and internationally (to Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia).

Affected healthcare facilities and service providers should contact Philips North America to obtain corrected warning labels for the cooling cabinet.

The recalled product

Product
SmartPath to dStream for 1.5T, Model No. 781260, 782112
Manufacturer
Philips North America
Category
Medical Device — Diagnostic Imaging Equipment
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. 782112 UDI-DI 00884838098886 Serial Numbers 30089 20204

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 →

Related recalls

Same manufacturer · Philips North America

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Same hazard · electrical shock

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