Intelli-C Accessory recallZ-0526-2022 · Nrt X-Ray A/S · initiated Jan 21, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nrt X-Ray A/S or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
On 01/11/2022, NRT issued an Urgent Medical device correction, which includes the following action to be taken by the users. 1. Identified the affected accessories as described in the Urgent Medical Device Correction Letter. 2. Inspect the Footrest and Shoulder Support which use the same clamping mechanism and should be inspected in the same way. The clamping mechanism consists of two clamping profiles, one for each side of the tabletop. Both sides should be inspected. a. The friction rubber that must be inspected is placed inside the clamping profile. It is the thick rubber, which must be firmly in place. The rubber is glued on the profile, and you should look for the overall adhesion. If slightly pressed from each side and end, the rubber should not show signs of detachment from the profile. If the rubber is firmly in place, you may continue use the equipment. If the rubber is detaching along either side or end, do not use the accessory until the repair has been made. 3. Return the response card in page 4, with the results and date of the inspection and your signature, not later than February 15, 2022. to [email protected]. 4. Follow up will be made in regards to the repair in April 2022, which will be coordinated with US dealer Alpha Imaging in Willoughby, Ohio. For any question contact (300) 696-0004 or E-Mail at [email protected].
Recall details
- Recall number
- Z-0526-2022
- Status
- Open, Classified
- Initiated by the company
- Jan 21, 2022
- Recalling firm
- Nrt X-Ray A/S
- Quantity
- 72 units
- Product code
- OWB
- FDA submissions
- K173631
- Distribution
- USA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic, Germany, Denmark, Netherlands, RSA, Sweden
Product description
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Intelli-C Accessory 03282000Nrt - Nordisk Røntgen Teknik A/S · Interventional Fluoroscopic X-Ray System1 recall1 report
- Intelli-C Accessory 03283000Nrt - Nordisk Røntgen Teknik A/S · Interventional Fluoroscopic X-Ray System1 recall0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K173631 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Intelli-C Left Side Suspended Table 03400010Nrt - Nordisk Røntgen Teknik A/S · System, X-Ray, Fluoroscopic, Image-Intensified2 recalls1 report
- Intelli-C Right Side Suspended Table 03400000Nrt - Nordisk Røntgen Teknik A/S · Interventional Fluoroscopic X-Ray System2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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