Philips Ingenuity Core CT Scanner Software Recall
Philips is recalling 105 Ingenuity Core CT scanners because software may set the scan length differently than planned 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. The hazard involves a software error that alters scan parameters, which is a risk-of-harm product defect where specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported or is theoretical.
Plain-English summary
Philips Electronics North America Corporation is recalling 105 units of the Philips Healthcare Ingenuity Core 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 (2 axis) scan length to a different length than the user set in the plan.
The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries such as Argentina, Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, and the United Kingdom. The specific code information for the affected units is 728321.
Healthcare facilities should contact Philips Electronics North America Corporation for instructions on how to resolve the software issue. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- Philips Healthcare Ingenuity Core 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)
- 728321
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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