Recall Z-1669-2023— NRT X-RAY A/S

Name: FDA recall Z-1669-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-27

Class II · Ongoing

Class II FDA medical device recall by NRT X-RAY A/S, initiated 2023-04-27. It names one FDA 510(k) clearance: K173631. Product: Intelli-C, Left side suspended Tabletop, REF: 03400010. Reason: 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..

Recalling firm: NRT X-RAY A/S
Classification: Class II
Status: Ongoing
Initiated: 2023-04-27
Firm location: Hasselager, N/A, Denmark

510(k) clearances named in this recall

1 on FDA's record

K173631 — Intelli-CNrt X-Ray A/S·cleared 2018-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.