Z-0475-2013Class II

Philips Digital Diagnost Software Version R2.0.2

Name: Z-0475-2013 Philips Digital Diagnost Software Version R2.0.2
Creator: Philips Healthcare Inc.
Published: 2012-10-30
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-10-30 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics on 2012-10-30. FDA classified it as Class II and gives the reason as "With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0475-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-30
Posted: 2012-12-05
Terminated: 2017-01-17
Recalling firm: Philips North America LLC
Product: Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side.
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare initiated a recall on October 25, 2012 via Urgent - Field Safety Notice for the Digital Diagnost X-ray System. The letter identified the affected product, problem and actions to be taken. The letter informs customers that Philips will supply a software update kit to version 2.1.4. For questions please contact your local Philips representative 1-800-722-9377.
Quantity in commerce: 623 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, India, Indonesia, Iraq, Italy, Japan, Latvia, Lithuania, Libya, Malta, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK.
Product codes and lots: All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0475-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0475-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-04

Product code MQB

K982795Class IIPhilips Bucky VisionPhilips Medical Systems, Inc. / cleared 1998-11-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)