FDAMarch 23, 2024device

5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come with multiport adapters.

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

The hazard

Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns

What to do

FDA enforcement status: Ongoing

Brands named

philips ultrasoundphilips

UPCs

00884838116566008848381165730088483811658000884838116597008848381166030088483811661000884838116627

Recall history

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

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