Device product
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Z-0475-2013
Product summary
- Event
- Event 63619
- Status
- Terminated
- Classification
- Class II
- Quantity
- 623 units
- Official record key
device-enforcement:Z-0475-2013
Official wording
Reason: 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.
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.
Derived failure modes
-
Unknown
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.