Agency classClass IIOur severity:High FDA (Devices)·Z-1669-2023·Announced 2023-06-07

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Diagnostic Imaging / X-Ray Equipment
Hazard: mechanical-failure
uncontrolled-movement
Affected units: 13

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.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 2 recalled by NRT X-RAY A/S under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · NRT X-RAY A/S

See all →

High
X-ray C-arm Tabletop Recalled for Risk of Uncontrolled Motion
FDA (Devices) · 2024-05-15
High
Medical Device Recall: X-Ray Detector Drive Shaft May Break
FDA (Devices) · 2023-06-07
High
Footrest accessory recalled for missing friction rubber block
FDA (Devices) · 2022-02-02

Same hazard · mechanical failure