FDA Device recall Z-1392-2018
Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emi…
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emi… by Philips Medical Systems Cleveland, citing following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1392-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-15 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Ingenuity 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. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for diagnostic study and therapeutic planning. The system also provides tools for the quantification of results of the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease.
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.
Identifiers
| code_info | Serial No: 2090 2072 2077 2079 2086 2091 2093 2085 2076 2071 2078 2081 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1392-2018%22
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