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FDA (Device enforcement)Recalled 2023-12-29class iii

Philips North America: SmartPath to dStream for 1.5T, Model No. 781260, 782112

Hazard

An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.

Details from the source

Reason for recall: An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel. Distribution: Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia. Quantity: 7 US; 16 ROW total Lot/code info: Model No. 781260 UDI-DI 00884838095076 Serial Numbers 21020 9024 8657 21200 21223 18948 32131; Model No. 782112 UDI-DI 00884838098886 Serial Numbers 30089 20204

UPC codes

00884838095076, 00884838098886

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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