Reported Mar 25, 2020 · Terminated

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

Philips North America, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
Lot codes and dates
  • 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
Amount recalled
70

This recall covers 10 products

The agency filed one notice per product. You are reading one of them; the other 9 are below.

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 17, 2022 · Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.