DRX Revolution Mobile X-Ray System — Class II medical device recall Z-0437-2024
Ongoing recall by Carestream Health, Inc., reported 2023-12-13, distributed nationwide. Unexpected failure of electrical components within the CPI generator.
| Recall number | Z-0437-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health, Inc., Rochester, NY, United States |
| Recall initiated | 2023-10-02 |
| Classified | 2023-12-01 |
| Reported by FDA | 2023-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, DE, DK, DZ, ES, FI, FR, GB, GH, HK, HU, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, LK, MA, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RS, SA, SE, SG, SI, TH, TR, TW, VN, ZA |
| Quantity | 3,961 units |
| UPC / GTIN / UDI-DI | 60889971019394 |
| Serial numbers | 1000, 1002, 1009, 101, 1027, 1030, 1033, 1035, 1036, 1037, 1038, 1039, 1040, 1041, 1042, 1043, 1044, 1045, 1046, 1047, 1048, 1049, 1050, 1051, 1054 and 475 more |
| Model numbers | 1019397, 1023415, 1023423, 1030717, 1030725, 1044726, 1060177, 8608754, 8610180, 8618894 |
Product
DRX Revolution Mobile X-Ray System
Reason for recall
Unexpected failure of electrical components within the CPI generator.
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-0437-2024. 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.