Philips Ingenuity TF PET/CT Recalled for Unresponsive Acquisition Console
Philips is recalling 12 Ingenuity TF PET/CT systems because the mass storage device may cause the acquisition console to become unresponsive, preventing image acquisition.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no injuries or illnesses have been reported. The hazard is a functional failure (unresponsive console) that prevents image acquisition, which fits the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported, but is not a high-risk pathogen or structural defect causing immediate physical harm.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 12 units of the Ingenuity TF PET/CT, Model No. 882442. The recall is due to a defect in the mass storage device that may cause the acquisition console to become unresponsive after a period of inactivity. This malfunction may prevent an acquisition from proceeding.
The affected devices were distributed worldwide, including in the United States (Ohio and Oregon) and in Australia, China, Cuba, France, and South Africa. The specific serial numbers for the recalled units are 2090, 2072, 2077, 2079, 2086, 2091, 2093, 2085, 2076, 2071, 2078, and 2081.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- 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 anato
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 12
Distribution
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