Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Recall
- Recall Number
- Z-0475-2013
- Event Number
- 63619
- Firm
- Philips Healthcare Inc.
- FEI Number
- 1218950
- Product Code
- MQB
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- October 30, 2012
- Posted
- December 5, 2012
- Terminated
- January 17, 2017
- Address
- 3000 Minuteman Road, Andover, MA, 01810
Description
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
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.
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.
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.
623 units