Recall Z-2199-2015 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
| Date | Jul 22, 2015 (initiated Jul 1, 2015) |
| Status | Terminated |
| Reason | Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue. |
| Root cause | Software design |
| Action | On 7/6/2015 the firm sent Field Safety Notices to their customers. |
| Quantity | 44 Units |
| Distribution | Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081135 | GEMINI CONDOR Philips Medical Systems (Cleveland), Inc., Apr 29, 2008 |