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Recall Observatory FDA recall evidence

Device product

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

Z-1669-2023

April 27, 2023

Class II

Product summary

Firm
NRT X-RAY A/S
Event
Event 92230
Status
Ongoing
Classification
Class II
Quantity
13 units
Official record key
device-enforcement:Z-1669-2023

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:05713464000121/Serial Numbers: 647009, 651002, 651006, 666009, 682003

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.