Recall Z-0900-2013 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Healthcare Inc.
Philips Digital Diagnost Stationary radiographic system
| Date | Mar 1, 2013 (initiated Oct 30, 2012) |
| Status | Terminated |
| Reason | When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image. |
| Root cause | Software design |
| Action | Philips Healthcare issued an Urgent Field Safety Notice dated October 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to review the information contained in the Notice with all member of their staff who need to be aware of the contents. Also, customers were asked to retain a copy with the equipment Instruction for Use. For further information or questions customers were instructed to contact their local Phillips representative Technical Support Line at 1-800-722-9377. For questions regard |
| Quantity | 360 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico, Netherlands, New Zealand, Norway , Oman, Panama, Peru, Poland, Qatar, Reunion, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982795 | PHILIPS BUCKY VISION Philips Medical Systems, Inc., Nov 24, 1998 |