FDA-Device2023-06-07Class II

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

NRT X-RAY A/S
Hazard

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.

Sold states
US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.
Affected count
13 units
Manufactured in
Birkegardsvej 16, N/A, Hasselager, N/A, Denmark
Products
Intelli-C, Left side suspended Tabletop, REF: 03400010

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1669-2023

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