FDA-Device2016-07-27Class II
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
Carestream Health Inc
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.
Sold states
Worldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy.
Affected count
7 Units (US: 5 units, OUS: 2 units)
Manufactured in
150 Verona St, N/A, Rochester, NY, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2217-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief