Philips Recalls GEMINI PET/CT Systems Due to Servo Controller Failure Risk
Philips is recalling 264 GEMINI PET/CT systems because the CT subsystem's Spindle Block Servo Controllers may fail prematurely.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential for premature component failure without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 264 units of the GEMINI PET/CT System. These are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
The recall is being conducted to determine if the Spindle Block Servo Controllers on the CT subsystem of the affected systems are susceptible to premature failure. The affected units were distributed worldwide, including to specific states in the United States and numerous international countries.
Healthcare facilities and consumers with these specific models and serial numbers should contact Philips Medical Systems for further instructions on how to address the potential servo controller issue.
The recalled product
- 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.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 264
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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