Recall Z-0121-2008 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application.
| Date | Nov 7, 2007 (initiated Sep 27, 2007) |
| Status | Terminated |
| Reason | The maximum intensity projection (MIP) images produced from respiratory gated images by the Tumor Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners will be labeled incorrectly for certain patient orientations and view conventions when saved for later viewing. |
| Root cause | Software design |
| Action | Notification letters were sent to the installed customer base informing them of the hazard on 10/1/2007. A mandatory corrective software release due out mid October 2007, will be available at no cost to the customer. The software will be installed by Philips Field Service Engineers. |
| Quantity | 206 systems |
| Distribution | Worldwide, including USA, Canada, France, Finland, Korea, Australia, Italy, Switzerland, China, Austria, Thailand, Malaysia, Denmark, Norway, Jordan, Netherlands, England, South Africa, Spain, Germany, Bahrain, Belgium, New Zealand, Puerto Rico, South Korea, Saudi Arabia, Czech Republic, Sweden, Isr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc., Jan 9, 2004 |