Class II — NRT X-RAY A/S
| Recalling firm | NRT X-RAY A/S |
|---|---|
| Registered facility | NRT X-RAY A/S (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system |
| Quantity | 35 |
| Distribution | US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, WV, LA, NY, PA, HI, NV, WI, MN, MI. |
| Initiated | 2024-04-17 |
| Classified | 2024-05-07 |
| Recall number | Z-1784-2024 |
| 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 — NRT X-RAY A/S (Z-1784-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94363/
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