Philips Ingenuity TF PET/MRI Recalled for Incorrect Chemical Shift Imaging Data
Philips Medical Systems is recalling 10 Ingenuity TF PET/MRI systems because the spectroscopy voxel map did not align with anatomical images, resulting in incorrect orientation of Chemical Shift Imaging data.
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, but the source text describes a data alignment issue without reporting any injuries, illnesses, or hospitalizations. This fits the criteria for a moderate severity score involving low-risk issues or voluntary precautionary measures where harm has not been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 10 units of the Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) system, model 882380. The affected devices are diagnostic imaging systems for fixed installations that combine PET and MRI technologies.
The recall was initiated because the spectroscopy voxel map did not align with the anatomical images of the phantom. This misalignment resulted in the incorrect orientation of the Chemical Shift Imaging (CSI) data. The affected serial numbers are 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014, and 24061.
The devices were distributed worldwide, including in the United States (New York, Ohio, and Texas) and in Finland, Germany, Japan, the Netherlands, South Korea, Spain, and Switzerland. The source text does not specify instructions for consumers or healthcare providers regarding corrective actions.
The recalled product
- Product
- Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 10
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 (10)
- Serial #'s: 11005
- 11006
- 11007
- 11008
- 11009
- 11010
- 11011
- 11012
- 11013
- 11014 & 24061.
Distribution
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