Philips CT Scanner Software Error May Alter Scan Length
Philips is recalling 105 Ingenuity Core 128 CT scanners because software may unexpectedly change the scan length during specific protocols.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical imaging) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Electronics North America Corporation is recalling 105 units of the Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system. The recall is due to a software defect where, during scans with specific protocol steps, the system unexpectedly sets the Axial (Z axis) scan length to a different length than the user set in the plan.
The affected units were distributed worldwide, including in the United States and numerous other countries. The source text does not specify the exact number of patients affected or report any specific injuries or illnesses resulting from this defect.
Healthcare facilities should contact Philips for instructions on how to address the software issue. Patients who have undergone scans on these systems should consult their healthcare provider if they have concerns about the accuracy of their imaging results.
The recalled product
- Product
- Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 105
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)
- 728323
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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