Reported Mar 11, 2015 · Terminated

Philips Medical System Allura Xper X-Ray Angiographic

Philips Medical Systems, Inc.

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 Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • Philips Medical System Allura Xper X-Ray Angiographic
Lot codes and dates
  • Software releases
    • PBL 10
    • 20
    • 30
    • 40
    • 50
    • and 60
    • CV20
    • R7.2x
    • R7.6
    • R8.1
    • and R8.2
Amount recalled
7439

Where it was sold

  • Nationwide
  • PR

Why it was recalled

In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound.

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 Oct 15, 2021 · Data as of Sep 19, 6:53 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.