CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a… — Class II medical device recall Z-2449-2015
Terminated recall by Carestream Health Inc, reported 2015-09-02, distributed nationwide. Software defect that impacts image alignment when using the automatic stitching option for long length images.
| Recall number | Z-2449-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health Inc, Rochester, NY, United States |
| Recall initiated | 2015-08-07 |
| Classified | 2015-08-21 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2016-07-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CL, CN, IN, KR, MY, NZ, SG, TH, TW |
| Reason classes | software |
| Serial numbers | 4004, 4058, 4064, 4067, 4069, 4073, 4074, 4076, 4082, 4084, 4085, 4086, 4096, 4097, 4099, 4100, 4113, 4117, 4125, 4131, 4143, 4146, 4156, 4172, 4192 and 149 more |
Product
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.
Reason for recall
Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.
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-2449-2015. 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.