Reported Sep 2, 2015 · Terminated

Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost…

Philips Electronics North America Corporation

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 Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

    • Philips DigitalDiagnost Release 4.0.3
    • Release 4.1/4.1.1. excluding
  • systems with SP1 Product UsageThe DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians
Lot codes and dates
  • DigitalDiagnost
Amount recalled
62

Where it was sold

Why it was recalled

The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal due to a defect in the Microsoft Windows 7 operating system.

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 Jan 17, 2017 · Data as of Sep 19, 4:46 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.