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.
This recall has been terminated (originally issued March 23, 2015).
- Recall Initiated
- March 23, 2015
- Terminated
- January 17, 2017
- Recall Number
- Z-2383-2015
- Quantity
- 62
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide Distribution to the states of : Arizona, Minnesota, State of Washington, Wyoming and Ohio. Internationally to Canada.
Lot / Code Info
DigitalDiagnost
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.