Carestream Touch Prime — Class II medical device recall Z-2217-2016
Terminated recall by Carestream Health Inc, reported 2016-07-27, distributed in GA, IA, TX. A software issue related to the generic volume measurement functionality could result in the volume of the sub
| Recall number | Z-2217-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health Inc, Rochester, NY, United States |
| Recall initiated | 2016-07-08 |
| Classified | 2016-07-18 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2017-05-02 |
| Distributed | GA, IA, TX |
| Countries outside the US | IT |
| Reason classes | software |
| Serial numbers | 1021, 1037, 1038, 1041, 1043, 1067, 1079 |
| Model numbers | 1738822, 1738830 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2217-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.