X-ray C-arm Tabletop Recalled for Risk of Uncontrolled Motion
NRT X-RAY A/S recalls Intelli-C X-ray tabletops due to faulty firmware and worn motor components that may cause uncontrolled C-arm motion, potentially striking patients or operators.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall describing a risk-of-harm product—the C-arm could potentially strike a patient or operator. However, the source text does not report any actual injuries, hospitalizations, or confirmed incidents. The hazard requires four specific conditions to occur simultaneously, qualifying this as a theoretical risk of harm without reported injury.
Plain-English summary
NRT X-RAY A/S is recalling the Intelli-C right-side and left-side suspended tabletops (REF 03400000 and 03400010) used with Intelli-C X-ray systems. The recall affects 35 units distributed nationwide across 15 U.S. states.
The C-arm may experience uncontrolled motion when four conditions occur together: the motor controller firmware has a faulty setting, the motor or gear assembly is worn, the C-arm is driven at maximum speed and angulated more than 75 degrees from vertical, and the emergency stop or touch guard is activated during the braking sequence. If these conditions align, the C-arm could strike a patient or operator.
Healthcare facilities and users of affected Intelli-C systems should immediately contact NRT X-RAY A/S regarding firmware updates or device replacement. Affected devices are identified by specific serial numbers provided in the recall notice (REF 03400000 and 03400010 with corresponding UDI-DI codes and individual serial numbers).
The recalled product
- Product
- Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
- Manufacturer
- NRT X-RAY A/S
- Hazard
- uncontrolled-motion
- impact-injury
- firmware-defect
- mechanical-wear
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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