The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1668-2023·Announced 2023-06-07

Medical Device Recall: X-Ray Detector Drive Shaft May Break

The FDA is recalling 32 X-ray detector units due to a potential drive shaft failure that could cause uncontrolled detector movement. Affected units are distributed in 10 US states.

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: This recall is classified as FDA Class II. The hazard involves potential mechanical failure of the drive shaft without any reported injuries or hospitalizations, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

The FDA has issued a recall of 32 units of the Intelli-C Right side suspended Tabletop X-ray detector component (REF: 03400000) manufactured by NRT X-RAY A/S. The recall is due to a potential defect in the drive shaft that controls the detector's up/down movement.

If the drive shaft breaks, the detector may continue moving until it reaches the mechanical end-stop, potentially posing a safety risk to operators and patients during use.

The affected units are identified by UDI-DI 05713464000527 and specific serial numbers (627004, 627007, 639001, 639002, 639003, 639004, 639007, 639010, 647001, 647004, 647005, 648001, 651007, 658002, 658003, 658006, 658010, 666008, 675001, 675004, 682006, 682010). These units have been distributed nationwide to healthcare facilities in Ohio, North Carolina, Kentucky, South Carolina, Iowa, Massachusetts, Washington, Louisiana, Nevada, and New York.

Healthcare facilities using this equipment should contact the manufacturer or the FDA for instructions on inspection and corrective action.

The recalled product

Product
Intelli-C, Right side suspended Tabletop, REF: 03400000
Manufacturer
NRT X-RAY A/S
Category
Medical Device — X-Ray Equipment
Hazard
Affected units
32

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)

  • UDI-DI: 05713464000527/Serial Numbers: 627004
  • 627007
  • 639001
  • 639002
  • 639003
  • 639004
  • 639007
  • 639010
  • 647001
  • 647004
  • 647005
  • 648001
  • 651007
  • 658002
  • 658003
  • 658006
  • 658010
  • 666008
  • 675001
  • 675004

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 →

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