Intelli-C — Class II medical device recall Z-1669-2023
Ongoing recall by NRT X-RAY A/S, reported 2023-06-07, distributed nationwide. There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may brea
| Recall number | Z-1669-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NRT X-RAY A/S, Hasselager, N/A, Denmark |
| Recall initiated | 2023-04-27 |
| Classified | 2023-05-31 |
| Reported by FDA | 2023-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 13 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05713464000121 |
| Serial numbers | 647009, 651002, 651006, 666009, 682003 |
| Model numbers | 03400010 |
Product
Intelli-C, Left side suspended Tabletop, REF: 03400010
Reason for recall
There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.
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-1669-2023. 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.