Philips Ingenuity TF PET/CT Software Update Corrects Multiple Issues
Philips is issuing a software update for 24 Ingenuity TF PET/CT systems to correct multiple issues identified in the previous software version.
What this means for you
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. The source text describes a software update to correct issues but does not report any injuries, illnesses, or specific high-risk hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is issuing a software update for the Ingenuity TF PET/CT (non-RoHS), Model Number 882456. This diagnostic imaging system combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) to produce cross-sectional images and images of radiopharmaceutical distribution. The recall involves 24 units with serial numbers ranging from 2003 to 2027.
The software update is being issued to correct multiple issues identified in the previous software version. The source text does not specify the exact nature of these issues or report any associated injuries or illnesses.
The affected devices were distributed worldwide, including in the United States (California, Illinois, New York, Ohio, and Pennsylvania) and in Australia, Austria, Columbia, Egypt, France, Germany, India, Italy, Lithuania, Netherlands, and Switzerland. Users should contact the manufacturer to obtain and install the software update.
The recalled product
- Product
- Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction o
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 24
Distribution
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