CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report
Ingenuity TF PET/CT recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling Ingenuity TF PET/CT, distributed nationwide in the US. The recall was initiated on 15 Feb 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1392-2018
- FDA event ID
- 79696
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Feb 2018
- FDA classified
- 17 Apr 2018
- Reported
- 25 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 15 Feb 2018 | Recall initiated by company | |
| 17 Apr 2018 | Classified by FDA | +61 days |
| 25 Apr 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US Nationwide in the states of: OH and OR, and Foreign distribution to Australia, China, Cuba, France, and South Africa.
Questions about this recall
Why was it recalled?
Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
Which lots are affected?
Serial No: 2090 2072 2077 2079 2086 2091 2093 2085 2076 2071 2078 2081
Where was it sold?
Worldwide Distribution - US Nationwide in the states of: OH and OR, and Foreign distribution to Australia, China, Cuba, France, and South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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