Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
This recall has been terminated (originally issued December 5, 2012).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- October 30, 2012
- Posted
- December 5, 2012
- Terminated
- January 17, 2017
- Recall Number
- Z-0475-2013
- Quantity
- 623 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022
Root Cause
Software design
Action Taken
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.