Intelli-C: Right side suspended Tabletop, REF: 03400000 recallZ-1784-2024 · Nrt X-Ray A/S · initiated Apr 17, 2024
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
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.
FDA root cause category: Device Design
What the company is doing
On 04/17/24, correction notices were emailed to consignees who were asked to do the following: 1) If you experience the described uncontrolled motion, stop using the device and contact your service provider to have your device repaired. 2) The correction notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. 3) Complete and return the response form to either [email protected] or [email protected] A firmware update will be made to all motor controllers in the system. The update will be performed by the Service Provider. Customers with recall-related questions can call 1-800-331-7327.
Recall details
- Recall number
- Z-1784-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 17, 2024
- Posted by the FDA
- May 7, 2024
- Recalling firm
- Nrt X-Ray A/S
- Quantity
- 35
- Product code
- OWB
- FDA submissions
- K173631
- Distribution
- US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, WV, LA, NY, PA, HI, NV, WI, MN, MI.
Product description
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
Code information (models, lots, serial numbers)
REF/UDI-DI/Serial Numbers: 03400000/05713464000527/627002, 627004, 627007, 639001, 639002, 639003, 639004, 639007, 639010, 647001, 647004, 647005, 648001, 651007, 658002, 658003, 658006, 658010, 666008, 675001, 675004, 682006, 682010, 682011, 696003, 696004, 696006, 696007, 696012. 03400010/05713464000121/647009, 651002, 651006, 666009, 682003, 682023
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- 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
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 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
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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