Recall Z-2383-2015 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Electronics North America Corporation
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.
| Date | Mar 23, 2015 |
| Status | Terminated |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| 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. |
| Quantity | 62 |
| Distribution | US Nationwide Distribution to the states of : Arizona, Minnesota, State of Washington, Wyoming and Ohio. Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141736 | PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST Philips Medical Systems Dmc GmbH, Jul 25, 2014 |