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Philips Electronics North America Corporation recalls Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDia
Recalled September 2, 2015 · FDA recall Z-2383-2015 · Philips Electronics North America
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. · FDA Class II
Units
62
Sold at
US Nationwide Distribution to the states of : Arizona, Minnesota, State of Washington, Wyoming and Ohio. Internationally to Canada.
Description
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.
Product
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.
Manufacturer(s)
Philips Electronics North America Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →