Recall Z-0110-2008 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance CT Systems, 40 slice configuration. Computed tomography scanner.
| Date | Oct 31, 2007 (initiated May 25, 2007) |
| Status | Terminated |
| Reason | Two potential artifacts may appear in some images from head scans on the Brilliance 40/64 systems. These artifacts may lead to misdiagnosis. |
| Root cause | Software design |
| Action | Firm notified its customers via a Product Safety Notification letter dated May 25, 2007, warning the user of a possible appearance of artifacts which could lead to a misdiagnosis and improper treatment. |
| Quantity | 404 |
| Distribution | Worldwide, including USA, Canada, Argentina, Austria, Australia, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Denmark, Ecuador, Egypt, England, Equatorial Guinea, Finland, France, Germany, Greece, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Korea, Lebanon, Libya, Malaysia, Mexico, Mor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc., Oct 29, 2003 |