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Carestream Health Inc recalls Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name:
Recalled July 27, 2016 · FDA recall Z-2217-2016 · Carestream Health
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. · FDA Class II
Units
7 Units (US: 5 units, OUS: 2 units)
Sold at
Worldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy.
Description
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.
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
Manufacturer(s)
Carestream Health Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →