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

Philips North America: Achieva 1.5T, Model No. 781178, 781196, 781296

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. 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

UPC codes

00884838004108

Source

Official record: FDA (Device enforcement)

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

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