Recall Z-0545-2016 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance iCT Computed Tomography X-ray system
| Date | Dec 24, 2015 (initiated Oct 29, 2015) |
| Status | Terminated |
| Reason | Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2. |
| Root cause | Software design |
| Action | On 10/30/2015 the firm sent Customer Information letters to their Consignees. |
| Quantity | 51 Units |
| Distribution | Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zeala |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |