Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET...
FDA Recall #Z-1029-2013 — Class II — December 20, 2012
Product Description
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Reason for Recall
Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.
Recalling Firm
Philips Medical Systems (Cleveland) Inc — Cleveland, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1
Distribution
Distributed to one customer in Ohio.
Code Information
Model #: 882456; Serial #: 2004
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated