—#139186

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.

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141736
Affected lot / code info: DigitalDiagnost

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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

Timeline

Recall initiated: 2015-03-23
Terminated: 2017-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139186. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.