Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
FDA Recall #Z-1487-2020 — Class II — December 30, 2019
Product Description
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
Reason for Recall
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.
Recalling Firm
Philips North America, LLC — Andover, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
70
Distribution
Nationwide domestic distribution. Foreign distribution worldwide.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated