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Recall Observatory FDA recall evidence

Device 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.

Z-2383-2015

March 23, 2015

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 71838
Status
Terminated
Classification
Class II
Quantity
62
Official record key
device-enforcement:Z-2383-2015

Official wording

Reason: 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.

Code information: DigitalDiagnost

Distribution pattern: US Nationwide Distribution to the states of : Arizona, Minnesota, State of Washington, Wyoming and Ohio. Internationally to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.