X-Ray Machine Detector May Move Unexpectedly Due to Drive Shaft Failure
FDA recalls the Intelli-C X-Ray machine's left side suspended tabletop model due to potential drive shaft failure in the detector lift mechanism, which could cause uncontrolled detector movement.
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: FDA Class II medical device recall with potential mechanical failure that could cause uncontrolled equipment movement. The hazard is theoretical with no reported injuries or illnesses, meeting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
The FDA has issued a Class II recall of the Intelli-C Left side suspended Tabletop (REF: 03400010) manufactured by NRT X-RAY A/S. This tabletop is a component used in X-ray diagnostic imaging equipment.
There is a potential that the drive shaft in the detector up/down movement mechanism may break. If the drive shaft fails, the detector could move unexpectedly until it is stopped by the movement end-stop. This could result in unintended movement of the equipment during diagnostic procedures.
The recall affects 13 units distributed nationwide in the following states: Ohio, North Carolina, Kentucky, South Carolina, Iowa, Massachusetts, Washington, Louisiana, Nevada, and New York. Affected serial numbers are 647009, 651002, 651006, 666009, and 682003.
Healthcare facilities with affected equipment should contact NRT X-RAY A/S or the FDA for guidance on whether their specific unit is affected and what remedial actions to take.
The recalled product
- Product
- Intelli-C, Left side suspended Tabletop, REF: 03400010
- Manufacturer
- NRT X-RAY A/S
- Hazard
- mechanical-failure
- uncontrolled-movement
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 (5)
- UDI-DI:05713464000121/Serial Numbers: 647009
- 651002
- 651006
- 666009
- 682003
Distribution
Distributed nationwide across the United States.
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