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.
Reported: September 2, 2015 Initiated: March 23, 2015 #Z-2383-2015
Product Description
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.
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.
Details
- Recalling Firm
- Philips Electronics North America Corporation
- Units Affected
- 62
- Distribution
- US Nationwide Distribution to the states of : Arizona, Minnesota, State of Washington, Wyoming and Ohio. Internationally to Canada.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Philips Electronics North America Corporation. Units affected: 62.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 2, 2015. Severity: Moderate. Recall number: Z-2383-2015.
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