FDA-Device2015-09-02Class II
Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.
Philips Electronics North America Corporation
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 due to a defect in the Microsoft Windows 7 operating system.
Sold states
US Nationwide Distribution to the states of : Arizona, Minnesota, State of Washington, Wyoming and Ohio. Internationally to Canada.
Affected count
62
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2383-2015Don't want to check this manually?
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