Cl II Carestream Touch Prime

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


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.

7 units

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


About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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