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 | Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left. |
| Product | 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices) |
| Quantity | 72 units |
| Distribution | USA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic, Germany, Denmark, Netherlands, RSA, Sweden |
| Initiated | 2022-01-21 |
| Classified | 2022-01-25 |
| Recall number | Z-0526-2022 |
| 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-0526-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89413/
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