FDA-Device2015-05-27Class II
Philips Healthcare DuraDiagnost X- Ray
Philips Medical Systems, Inc.
Hazard
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. This is a failure to comply with 21CFR 1020.31(j).
Sold states
Worldwide Distribution - Nationwide Distribution and the countries of Australia, Austria, Argentina, Canada, China, Chile, Colombia Czech Republic, Great Britain, Germany, Egypt, Finland, France, India, Ireland, Japan, Malaysia, Macedonia, Mexico, Netherlands, New Zealand, Nepal, Peru, Poland, Russia, Saudi Arabia Singapore, Switzerland, Sweden, Spain, United Arab Emirates and United Kingdom.
Affected count
3 DuraDiagnost
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips Healthcare DuraDiagnost X- Ray
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1555-2015Don't want to check this manually?
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