Philips Ingenuity TF PET/CT System Recalled for Gating Trigger Risk
Philips Medical Systems is recalling one Ingenuity TF PET/CT unit in Ohio because the system may not default to the correct gating trigger, posing a risk to patients.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling one unit of the Ingenuity TF PET/CT diagnostic imaging system. The recall involves a specific unit with Model # 882456 and Serial # 2004, which is currently running system software version 4.0.0.26635. This unit was distributed only in Ohio.
The recall was initiated because the system may not default to the same gating trigger with which the data were acquired. According to the source text, this malfunction could cause a risk for patients.
The source text does not provide specific instructions for consumers or healthcare providers on how to address the issue, nor does it report any specific injuries or illnesses. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Ingenuity TF PET/CT. Diagnostic imaging system
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 1
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)
- Model # 882456
Distribution
Distributed in 1 state:
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