RecallRadar

FDA Device recall Z-1668-2023

Intelli-C, Right side suspended Tabletop, REF: 03400000

On 2023-06-07 the FDA classified a Class II recall of Intelli-C, Right side suspended Tabletop, REF: 03400000 by Nrt X Ray A S, citing 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 moveme….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1668-2023
ClassificationClass II
Statusongoing
Initiated2023-04-27
Published2023-06-07
Last updated2026-09-13 11:56 UTC
CompanyNrt X Ray A S
DistributionUS

Product

Intelli-C, Right side suspended Tabletop, REF: 03400000

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.

Identifiers

code_info
UDI-DI: 05713464000527/Serial Numbers: 627004, 627007, 639001, 639002,639003, 639004, 639007, 639010, 647001, 647004, 6…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, 682006, 682010

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1668-2023%22

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