Recall Z-2383-2015— Philips Electronics North America Corporation

Name: FDA recall Z-2383-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-23

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-03-23, terminated 2017-01-17. It names one FDA 510(k) clearance: K141736. Product: 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: 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..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-03-23
Terminated: 2017-01-17
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K141736 — PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOSTPhilips Medical Systems Dmc GmbH·cleared 2014-07-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.