Z-2383-2015Class II

Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1

Name: Z-2383-2015 Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1
Creator: Philips Electronics North America Corporation
Published: 2015-03-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-03-23 / Terminated

FDA source

Philips Electronics North America Corporation began a recall of 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... on 2015-03-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2383-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-23
Posted: 2015-11-11
Terminated: 2017-01-17
Recalling firm: Philips North America LLC
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.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
FDA 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 in commerce: 62
Distribution: US Nationwide Distribution to the states of : Arizona, Minnesota, State of Washington, Wyoming and Ohio. Internationally to Canada.
Product codes and lots: DigitalDiagnost

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2383-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2383-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-22

Product code MQB

K141736Class IIPhilips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH / cleared 2014-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)