Device 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
Z-2217-2016
Product summary
- Event
- Event 74652
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 Units (US: 5 units, OUS: 2 units)
- Official record key
device-enforcement:Z-2217-2016
Official wording
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.
Code information: Touch Prime Serial Numbers: 1037, 1038; -- Touch Prime XE Serial Numbers: 1021, 1079, 1067, 1041, 1043
Distribution pattern: Worldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy.
Derived failure modes
-
Device software or design
software issue