Philips Ingenuity TF PET/CT Software Recall for Reconstruction Failures
Philips is recalling 24 Ingenuity TF PET/CT systems due to a software defect that causes intermittent PET reconstruction failures, rendering acquired data unusable.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 hazard is a software defect causing data loss (unusable images) rather than direct physical injury or death, fitting the criteria for a moderate severity issue involving functional failure without reported harm.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 24 units of the Ingenuity TF PET/CT (model 882442) running software version 4.0.2. The recall is due to a software issue that causes Positron Emission Tomography (PET) reconstructions to fail intermittently. The defect occurs when a negative table position value is inserted into the raw data list file instead of the actual table position.
The error manifests in two scenarios: when a system operator cancels an acquisition, or when couch position requests within the software sequence are delayed, particularly when the network is heavily loaded. In both cases, the acquisition data cannot be reconstructed and is therefore unusable. The affected units were distributed worldwide, with US distribution to California, Ohio, Illinois, Pennsylvania, and New York.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Ingenuity TF PET/CT (model 882442) running software version 4.0.2 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…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 24
Distribution
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