Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging Recalled by Philips Medical Systems (Cleveland) Inc Due to It was noticed that the spectroscopy voxel map...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems (Cleveland) Inc directly.
Affected Products
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).
Quantity: 10 units
Why Was This Recalled?
It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This resulted in incorrect orientation of the Chemical Shift Imaging (CSI) data.
Where Was This Sold?
This product was distributed to 3 states: NY, OH, TX
About Philips Medical Systems (Cleveland) Inc
Philips Medical Systems (Cleveland) Inc has 313 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report