PlainRecalls
FDA Devices Moderate Class II Terminated

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 of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imagin

Reported: February 20, 2019 Initiated: December 19, 2018 #Z-0823-2019

Product Description

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 of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging).

Reason for Recall

A software update is being issued to correct multiple issues identified in the previous software version.

Details

Units Affected
24
Distribution
Worldwide distribution: US (nationwide) to states of: CA, IL, NY, OH, and PA; and to countries of: Australia, Austria, Columbia, Egypt, France, Germany, India, Italy, Lithuania, Netherlands, and Switzerland.
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled? ▼
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 of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging).. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 24.
Why was this product recalled? ▼
A software update is being issued to correct multiple issues identified in the previous software version.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 20, 2019. Severity: Moderate. Recall number: Z-0823-2019.

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