Company: Carestream Health Inc
Date of Enforcement Report 7/27/2016
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 Number Z-2217-2016
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.
Carestream Health Inc, Rochester, NY on 7/8/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US Distribution to states of: GA, IA, and TX; and country of: Italy.