Reported Mar 25, 2020 · Terminated

Integris Allura 9, system codes 722018 722021

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 9
    • system codes 722018 722021
Lot codes and dates
  • Serial Codes 8 114 64 906187 41 38 119 75 25 87 67 107 32 97
Amount recalled
20

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, 6:54 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.