FDAJuly 8, 2016device

Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body

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

The hazard

A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appear enlarged or distended when it actually is not.

What to do

FDA enforcement status: Terminated

Brands named

carestream healthcarestream

Recall history

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

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Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body — Recall Details · AllClear