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Recall Observatory FDA recall evidence

Device product

Poly G Integris H5000, System code 72246

Z-1491-2020

December 30, 2019

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 84756
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1491-2020

Official wording

Reason: A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.

Code information: System equipment number 519212

Distribution pattern: Nationwide domestic distribution. Foreign distribution worldwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.