Device Recall GEMINI GXL

Model #: 882410; Serial #s: 3025, 4003, 4026, 4067, 4076, 4087, 4097, 4102, 4123, 4134, 4201, 4202, 4205, 4206 & 4042003.

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

Model #882410 GEMINI GXL 16 Slice (453567971891); Serial Number: 4170 & 4147A.

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 GXL 16 Slice 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.

Model # 882390, Serial # 4001, 4012, 4013, 4016, 4021-4023, 4025, 4034, 4038, 4042-4044, 4049, 4052-4054, 4059, 4062, 4074, 4081, 4086, 4092, 4098, 4100, 4103, 4119, 4120, 4124-4126, 4129, 4133,4135, 4142, 4153, 4154, 4157, 4159, 4161, 4163, 4164, 4166-4169, 4171, 4176, 4178, 4181, 4182, 4184, 4187, 4190, 4192 & 4196-4198.  Model # 882400, Serial # 4006, 4047, 4075, 4093, 4110, 4121, 4134 & 4138.  Model # 882410, Serial # 4003, 4004, 4007-4011, 4014, 4015, 4018-4020, 4024, 4026-4033, 4035-4037, 4039, 4040, 4041, 4045, 4046, 4048, 4050, 4051, 4055-4058, 4060, 4061, 4063-4073, 4076-4080, 4082-4085, 4087-4091, 4094-4097, 4099, 4101, 4102, 4104-4107, 4109, 4111-4117, 4122, 4123, 4127, 4128, 4130-4132, 4136, 4137, 4139-4141, 4143-4152, 4155, 4156, 4158, 4160, 4162, 4165, 4172-4175, 4177, 4179, 4180, 4183, 4185, 4186, 4188, 4189, 4191, 4193-4195, 4199, 4201-4206, 7421 & G-10.

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY. Product was also shipped to the following countries: Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakstan, Kenya, Kuwait, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Russian Fed, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom & Venezuela.

GEMINI GXL 6, 10 & 16 Computed Tomography X-Ray Systems, M/N 882390, 882400 & 882410, Distributed by: Philips Medical System, Cleveland, OH || Product Usage: The Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in:  The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders.  The detection, localization, and staging of tumors and diagnosing cancer patients.  Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

The affected Serial Numbers are:  4004, 4039, 4045, 4068, 4080, 4104, 4112, 4115, 4117, 4118, 4121, 4127, 4132, 4139, 4146, 4152, 4156, 4158, and 4175.

Radiology Devices

2

No

Worldwide distribution: USA, Puerto Rico, Canada, Belgium, China, Denmark, Egypt, France, Germany, Hong Kong, India, Japan, Netherlands, Pakistan, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, and Sweden.

Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems: GEMINI GXL 16 slice configuration, Model Number: 4535 679 75691.