Carestream Health Inc: Medical Device Recall in 2016 - (Recall #: Z-2217-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: July 8, 2016

Date Posted: July 27, 2016

Recall Number: Z-2217-2016

Event ID: 74652

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.

Status: Terminated

Product Quantity: 7 Units (US: 5 units, OUS: 2 units)

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.

Voluntary or Mandated:

Voluntary: Firm initiated