Philips Healthcare Inc.: Medical Device Recall in 2012 - (Recall #: Z-0475-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics

Product Classification:

Class II

Date Initiated: October 30, 2012

Date Posted: December 12, 2012

Recall Number: Z-0475-2013

Event ID: 63619

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.

Status: Terminated

Product Quantity: 623 units

Code Information:

All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated