Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Carestream Touch Prime Recalled by Carestream Health Inc Due to A software issue related to the generic volume...

Date: July 8, 2016
Company: Carestream Health Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Carestream Health Inc directly.

Affected 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

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

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 3 states: GA, IA, TX

Affected (3 states)Not affected

About Carestream Health Inc

Carestream Health Inc has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report