FDAClass IIJune 7, 2023

Intelli-C recall

Intelli-C, Left side suspended Tabletop, REF: 03400010

Why was Intelli-C recalled?

There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI:05713464000121/Serial Numbers: 647009, 651002, 651006, 666009, 682003

Product
Intelli-C, Left side suspended Tabletop, REF: 03400010
Recalling firm
NRT X-RAY A/S
Quantity
13 units
Distribution
US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.
Recall date
June 7, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls