Z-2217-2016 Class II Terminated
FDA device recall Z-2217-2016 was initiated by Carestream Health Inc on July 8, 2016 and is designated Class II. Reason for recall: 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 app… The recall status is terminated (terminated May 2, 2017). Affected quantity: 7 Units (US: 5 units, OUS: 2 units).
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2016
- Initiation Date
- July 8, 2016
- Termination Date
- May 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 Units (US: 5 units, OUS: 2 units)
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy.
Code Information
Touch Prime Serial Numbers: 1037, 1038; -- Touch Prime XE Serial Numbers: 1021, 1079, 1067, 1041, 1043