GEMINI LXL

Model: , Affected:

Model #: 882412; Serial #s: 14701, 14702, 14704, 14705, 14706, 14707, 14708, 14709, 14710 & 14711.

Radiology Devices

2

No

Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.

Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Model #882412 GEMINI LXL (459800018631); Serial Number: 14702 & 14707.

Radiology Devices

2

No

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.

GEMINI LXL 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.

TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI LXL, GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore (See attached for serial number)

X ray, Computed Tomography

GEMINI TF PET/CT 16 and GEMINI TF PET/CT 64 Software Version 3.5.1, GEMINI TF PET/CT 16 and GEMINI TF PET/CT 64 Software Version 35.1.1, GEMINI TF PET/CT 16, GEMINI TF PET/CT 64, GEMINI TF Ready and GEMINI LXL Software Version 3,5.2, GEMINI TF PET/CT 16 and GEMINI TF PET/CT 64 Software Version 3.5.2.1, GEMINI TF Big Bore Software Version 3.6;, GEMINI TF Big Bore Software Versions 3.6.1 and 3.6.2, TruFlight Select systems Software Version V3.5.3

PET Reconstruction Server (PRS) database