Recall archive / FDA device enforcement
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combina... — FDA record Z-0526-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 21, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
- 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.
- Classification
- Class II
- Recalling firm
- NRT X-RAY A/S
- Quantity
- 72 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0526-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1. Footrest, REF: 03282000, UDI: 05713464000336; Serial Numbers: 903282000046, 903282000057, 903282000075 ,9032820000070, 903282000001, 903282000002, 903282000004 thru 903282000006, 903282000009, 903282000011, 903282000012 903282000015, 903282000016, 903282000018 thru 903282000020, 903282000023, 903282000024, 903282000025, 903282000026, 903282000028, 903282000032 thru 903282000034, 903282000036, 903282000038 thru 903282000042, 903282000044, 903282000045, 903282000047 thru 903282000051, 903282000053, 903282000055, 903282000056, 903282000058 thru 903282000061, 903282000063, 903282000064, 903282000067, 903282000068 2. Shoulder Support, REF: 03283000, UDI: 05713464000381 Serial Numbers: 903283000012, 903283000028, 903283000001 thru 903283000003, 903283000005, 903283000010, 903283000011, 903283000013 thru 903283000022, 903283000023, 903283000024, 903283000026 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
USA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic, Germany, Denmark, Netherlands, RSA, Sweden
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 2, 2022
- Recall initiation date
- Jan 21, 2022
- Center classification date
- Jan 25, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.