Philips Medical Systems (Cleveland) Inc GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
Model Name Model NUmber and serial number GEMINI Dual 4535 679 00891 G097, G119, 101-103, 105-107, 109-117, 119-127, 131-144, 146-164, 1025, 2003506, 2003507, 1Z9Z591, 2Z9Z591, 3Z9Z591, 4Z9Z591, GY9Z591, HY9Z591, JY9Z591 GEMINI 16 Power 4535 679 58961 1002, 1004-1008, 1010-1015, 1017-1028, 1030-1034, 1035R, 1036A, 1037-1046, 101R, 1023a, G098, MNM4411 GEMINI GXL (6, 10, 16, and 16 Mobile) 4535 679 75691, 4535 679 81871, 4535 679 76581, 4535 679 71891 4001, 4003-4040, 4042-4089, 4091-4123, 4125-4127, 4129-4137, 4139-4143, 7011, 4097A, 4147a GEMINI TF 16 Slice (16, 64, 64 Mobile and 16 Base) 4535 679 83931, 4535 674 47551, 4535 679 94741, 4535 674 41711 7001, 7003-7006, 7008, 7009, 7013-7017, 7022, 7024, 7025, 7027, 7028
Products Sold
Model Name Model NUmber and serial number GEMINI Dual 4535 679 00891 G097, G119, 101-103, 105-107, 109-117, 119-127, 131-144, 146-164, 1025, 2003506, 2003507, 1Z9Z591, 2Z9Z591, 3Z9Z591, 4Z9Z591, GY9Z591, HY9Z591, JY9Z591 GEMINI 16 Power 4535 679 58961 1002, 1004-1008, 1010-1015, 1017-1028, 1030-1034, 1035R, 1036A, 1037-1046, 101R, 1023a, G098, MNM4411 GEMINI GXL (6, 10, 16, and 16 Mobile) 4535 679 75691, 4535 679 81871, 4535 679 76581, 4535 679 71891 4001, 4003-4040, 4042-4089, 4091-4123, 4125-4127, 4129-4137, 4139-4143, 7011, 4097A, 4147a GEMINI TF 16 Slice (16, 64, 64 Mobile and 16 Base) 4535 679 83931, 4535 674 47551, 4535 679 94741, 4535 674 41711 7001, 7003-7006, 7008, 7009, 7013-7017, 7022, 7024, 7025, 7027, 7028
Philips Medical Systems (Cleveland) Inc is recalling GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Po due to The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT system. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.
Recommended Action
Per FDA guidance
Philips field service personnel will conduct customer visits in order to inspect systems. For further questions please call (440) 483-7600.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CO, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MO, NE, NV, NJ, NM, NY, ND, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WV, WI, WY
Page updated: Jan 10, 2026