Intelli-C: Right side suspended Tabletop — Class II medical device recall Z-1784-2024
Ongoing recall by NRT X-RAY A/S, reported 2024-05-15, distributed nationwide. X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting,
| Recall number | Z-1784-2024 |
|---|---|
| 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 | 2024-04-17 |
| Classified | 2024-05-07 |
| Reported by FDA | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 35 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05713464000121, 05713464000527 |
| Serial numbers | 03400000/05713464000527/627002, 03400010/05713464000121/647009, 627004, 627007, 639001, 639002, 639003, 639004, 639007, 639010, 647001, 647004, 647005, 648001, 651002, 651006, 651007, 658002, 658003, 658006, 658010, 666008, 666009, 675001, 675004 and 10 more |
| Model numbers | 03400000, 03400010 |
Product
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
Reason for recall
X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.
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-1784-2024. 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.