Philips Ingenuity TF PET/CT Software Update Addresses Potential Safety Risks
Philips is updating software on one Ingenuity TF PET/CT system in Ohio to fix issues that could cause inaccurate readings or pose risks to patients and staff.
What this means for you
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 source text explicitly states that the issues 'could cause a risk for patients, users or service personnel' but does not report any actual injuries, illnesses, or deaths. This aligns with the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling one Ingenuity TF PET/CT diagnostic imaging system. The device is currently running software version 4.0.60605.0 and was distributed to a single customer in Ohio. The system combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) technologies.
The recall is due to detected issues in the current software version that, if they were to re-occur, could cause a risk for patients, users, or service personnel. These risks include the generation of inaccurate standard uptake values (SUV). Philips is issuing a software update to address these specific issues.
The affected unit is identified by Model # 882456 and Serial # 2004. Customers should contact Philips Medical Systems to obtain and install the necessary software update to mitigate the potential risks associated with the identified software issues.
The recalled product
- Product
- Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- 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 (2)
- Model #: 882456
- Serial #: 2004
Distribution
Distributed in 1 state:
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