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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