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Recall Observatory FDA recall evidence

Device product

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

Z-1668-2023

April 27, 2023

Class II

Product summary

Firm
NRT X-RAY A/S
Event
Event 92230
Status
Ongoing
Classification
Class II
Quantity
32 units
Official record key
device-enforcement:Z-1668-2023

Official wording

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.

Code information: 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

Distribution pattern: US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.