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Recall Observatory FDA recall evidence

Device product

Azurion FlexArm, 722079

Z-1130-2019

March 12, 2019

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 82469
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-1130-2019

Official wording

Reason: During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.

Code information: Serial numbers 637, 638

Distribution pattern: Distributed to one account in Florida, and one international account in Germany.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.