Philips Electronics North America Corporation recalls Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost…

Recall date

March 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2383-2015

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.