Philips Ingenuity TF PET/CT Software Recall for Potential Radiopharmaceutical Re-injection Risk
Philips is recalling 13 Ingenuity TF PET/CT systems due to software issues that could require patients to be re-injected with PET radiopharmaceuticals during rescans.
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 recall involves a high-risk medical device where a software defect could lead to unintended patient exposure to radiopharmaceuticals, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 13 Ingenuity TF PET/CT diagnostic imaging systems. These systems combine Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) for medical imaging. The recall involves Model # 882456 with serial numbers 2003-2013 and 2015-2019.
The recall is due to issues with Software Version 4.0. These issues could pose a risk to patients if a rescan requires the reinjection of PET radiopharmaceuticals. The affected units were distributed worldwide, including in the United States (specifically New York, Ohio, and Pennsylvania) and in Australia, Austria, Egypt, France, Germany, India, and the Netherlands.
Healthcare facilities using these systems should contact Philips Medical Systems for further instructions on how to address the software issue. Patients who have undergone scans on these systems should consult their healthcare providers if they have concerns regarding their specific imaging procedures.
The recalled product
- Product
- Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations 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 reconstruction of x-ray transmi
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 13
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 Number: 2003 -2013 and 2015 - 2019.
Distribution
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