Recall Z-0475-2013 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Healthcare Inc.
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
| Date | Dec 5, 2012 (initiated Oct 30, 2012) |
| Status | Terminated |
| 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. |
| 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 | 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, N |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982795 | PHILIPS BUCKY VISION Philips Medical Systems, Inc., Nov 24, 1998 |