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.
FDA Recall Z-2383-2015 · Posted None
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Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeMQB
Date Initiated2015-03-23
Date Terminated2017-01-17
Product Quantity62
Reason for Recall
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.
Firm Action
Philips Healthcare sent an Urgent Field Safety Notice letter dated June 25, 2015 to customers. The letter identified the affected product, problem and actions to be taken. Philips plans to install a software upgrade in affected systems, which will eliminate this issue. Philips Healthcare Field Service Engineers will schedule an appointment with customers to install the software update. For questions contact your local philips representative.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US Nationwide Distribution to the states of : Arizona, Minnesota, State of Washington, Wyoming and Ohio. Internationally to Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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