Apr

2018

Cl II Ingenuity TF PET/CT

Company:Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report 4/25/2018
Class lI:

PRODUCT

ngenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body.
Recall Number Z-1392-2018

REASON
Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.

RECALLING FIRM/MANUFACTURER
PPhilips Medical Systems (Cleveland) Inc, Cleveland, OH on 2/15/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
12

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Ingenuity TF PET/CT

Amy Sellers

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