FDANovember 10, 2022device

Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult a...

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

The hazard

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

What to do

FDA enforcement status: Ongoing

Brands named

ge medical systems

UPCs

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Recall history

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

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