Reported Nov 11, 2015 · Terminated
GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission…
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- 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.
- Lot codes and dates
- 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
- Amount recalled
- 264 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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