FDA (Devices) recall action 93788
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
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.
The agency’s own wording, quoted from the enforcement report.
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.
Philips MRI systems have an incorrect electrical shock warning label missing high-voltage symbols, risking shock to service personnel.
Some Philips Intera 1.5T MRI systems have an incorrect warning label on the Liquid Cooling Cabinet that fails to properly warn service personnel of electrical shock hazards.
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.
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.
Philips Ingenia Ambition X MRI systems contain an incorrect warning label on the cooling cabinet. The label is missing high-voltage warning symbols, creating a potential electrical shock risk for service personnel.