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Recall Observatory FDA recall evidence

Device product

Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)

Z-1487-2020

December 30, 2019

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 84756
Status
Terminated
Classification
Class II
Quantity
70
Official record key
device-enforcement:Z-1487-2020

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: Serial Codes 3217017 200 58 72 CV.170 180 524615 47 211 364 30 3862570/0011 529 S.N. 519 S01H060871 505/0050114 S01H057274 01H077213 530 532 S01HA52566 348 476 320 481 467 284 352 359 459 73*004 733 536 CV.474 454 49 281 51 186 122 250 37 22 CV.312 296 373 CV.596 176 30 580 279

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.