Company: Carestream Health Inc
Date of Enforcement Report 7/27/2016
Class lI:

PRODUCT

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

REASON
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.

RECALLING FIRM/MANUFACTURER
Carestream Health Inc, Rochester, NY on 7/8/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7 units

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

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