Class II — Carestream Health Inc
| Recalling firm | Carestream Health, Inc. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 7 Units (US: 5 units, OUS: 2 units) |
| Distribution | Worldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy. |
| Initiated | 2016-07-08 |
| Classified | 2016-07-18 |
| Terminated | 2017-05-02 |
| Recall number | Z-2217-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Carestream Health Inc (Z-2217-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74652/
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