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FDAJune 30, 2023device

3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.

What to do

FDA enforcement status: Completed

Brands named

philips ultrasoundphilips

UPCs

00884838061545

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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