Carestream Health Inc recalls Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name:…

Recall date

July 8, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2217-2016

FDA classification

Class II

Brand / firm

Carestream Health Inc

Sold / distributed

Worldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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