Ingenuity TF PET/CT — Class II medical device recall Z-1392-2018
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2018-04-25, distributed nationwide. Following a period of inactivity, the mass storage device may cause the acquisition console to become unrespon
| Recall number | Z-1392-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2018-02-15 |
| Classified | 2018-04-17 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2019-11-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CN, FR, ZA |
| Quantity | 12 |
| Serial numbers | 2071, 2072, 2076, 2077, 2078, 2079, 2081, 2085, 2086, 2090, 2091, 2093 |
| Model numbers | 882442 |
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 for recall
Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.