Medical device recalls Moderate risk

NRT X-RAY A/S recalls Intelli-C, Left side suspended Tabletop, REF: 03400010

Recall date
April 27, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1669-2023
FDA classification
Class II
Brand / firm
NRT X-RAY A/S
Sold / distributed
US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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