Recall Z-0479-2013 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
| Date | Dec 21, 2012 (initiated Sep 28, 2012) |
| Status | Terminated |
| Reason | Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues which will improve the overall quality and functionality of the EBW. |
| Root cause | Software design |
| Action | Philips sent a Urgent Medical Device Correction letter dated September 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips is issuing a system update to all of the Extended Brilliance Workspace (EBW) systems currently running software version 4.5.4. The update will provide a number of improvements to the overall quality and functionality of the EBW systems. If you need further information or support concerning this issue, please contact your local Philips representative. In the United States and Canad |
| Quantity | 265 units |
| Distribution | Worldwide Distribution--US (nationwide) including the states of AR, OH, OR, PA, TX VA & WI., and the countries of Algeria, Australia, Brazil, China, Ecuador, Finland, France, Germany, Hong Kong, India, Italy, Lebanon, Libyan Arab Jamahiriya, Russia, South Korea & United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961464 | SELECT/SP Elscint, Inc., Jul 3, 1996 |