Philips Ingenuity TF PET/CT Recalled for Missing Gantry Mounting Hardware
Philips is recalling two Ingenuity TF PET/CT systems because one wire channel inside the Gantry Separation Unit was missing mounting hardware.
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. The source text describes a missing mounting hardware defect but does not report any injuries, illnesses, or specific safety incidents, fitting the criteria for a moderate severity recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling two units of the Ingenuity TF PET/CT system. This is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system.
The recall was initiated because one of the two wire channels mounted inside the Gantry Separation Unit (GSU) was missing mounting hardware. This specific wire channel is also used to secure the top two GSU covers.
The affected units were distributed to one domestic consignee and one foreign consignee in Spain. The specific model number for the recalled units is 882442. The source text does not provide instructions for consumers or end-users, as this is a specialized medical device recall.
The recalled product
- Product
- Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Ingenuity TF PET/CT Model # 882442
Distribution
Distribution scope not specified by the agency.
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