Z-0823-2019 Class II Terminated
FDA device recall Z-0823-2019 was initiated by Philips Medical Systems (Cleveland) Inc on Dec 19, 2018 and is designated Class II. Reason for recall: A software update is being issued to correct multiple issues identified in the previous software version. The recall status is terminated (terminated Aug 3, 2021). Affected quantity: 24.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 20, 2019
- Initiation Date
- Dec 19, 2018
- Termination Date
- Aug 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
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.
Distribution Pattern
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.
Code Information
Serial Numbers 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0823-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026