Recall Z-1818-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Healthcare Inc.
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
| Date | Jun 15, 2012 (initiated May 22, 2012) |
| Status | Terminated |
| Reason | With Digital Diagnost (DIDI) R 2.0.2 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 change control |
| Action | Philips Healthcare issued a Field Safety Notice on 5/22/12 advising users of the error. A software update (Rel 2.1.2) will issue to correct the problem. Contact your local Philips representative. 1-800-722-9377. For questions regarding this recall call 978-687-1501. |
| Quantity | 752 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Canada AFGHANISTAN ALBANIA ALGERIA ANGOLA ARGENTINA ARMENIA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BAHRAIN BANGLADESH BARBADOS BELARUS BELGIUM BENIN BHUTAN BOLIVIA BOSNIA&HERZEGOVINA BRAZIL BRUNEI DARUSSALAM BULG |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982795 | PHILIPS BUCKY VISION Philips Medical Systems, Inc., Nov 24, 1998 |