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Recall Observatory FDA recall evidence

Device product

ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system

Z-0727-2021

December 08, 2020

Class II

Product summary

Firm
PHILIPS HOME HEALTHCARE SOLUTION
Event
Event 87039
Status
Terminated
Classification
Class II
Quantity
91
Official record key
device-enforcement:Z-0727-2021

Official wording

Reason: After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.

Code information: Pending

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.