—#179810

Product

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

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K002016
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

On December 30, 2019, the firm notified customers via Medical Device Correction letter. Customers were informed of the product issue and advised to do the following: If the capacitor of the Velara X-Ray fails as described (capacitor failure after large number of surges in a short period of time), please switch off the system, take it out of service immediately, and contact your local Philips representative. The firm will be resolving the issue by replacing a Printed Circuit Board (PCB) in the convertor, which prevents the capacitor from failing. PCB replacements started in January 2020. Customers will be contacted by their local Philips representatives to schedule a date for the PCB replacement. Customers with further questions should contact the Technical Support Line: 1-800-722-9377.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Nationwide domestic distribution. Foreign distribution worldwide.

Timeline

Recall initiated: 2019-12-30
Terminated: 2022-11-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179810. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.