Recall Z-2217-2016— Carestream Health Inc
Class II · Terminated
Class II FDA medical device recall by Carestream Health Inc, initiated 2016-07-08, terminated 2017-05-02. It names one FDA 510(k) clearance: K152467. 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. 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..
- Recalling firm
- Carestream Health Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-08
- Terminated
- 2017-05-02
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.