Philips Ingenuity Core 128 CT Systems Recalled for Software Reconstruction Failures
Philips is recalling 116 Ingenuity Core 128 CT systems worldwide because a software upgrade caused intermittent reconstruction failures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional software defect (incomplete reconstructions) without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary or functional recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling 116 units of the Ingenuity Core 128 Computed Tomography X-ray system. The recall is due to a software issue where reconstructions would intermittently fail to complete after upgrading from version 3.5.4 to 3.5.5.
The affected systems were distributed nationwide in the United States and in numerous countries including Australia, China, France, Germany, India, Japan, and the United Kingdom. The recall is classified as Class II by the FDA.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issue. No specific corrective action or consumer steps are detailed in the source text beyond the identification of the defect.
The recalled product
- Product
- Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 116
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 (20)
- System code: 728323
- Serial #: 320002
- 320003
- 320004
- 320005
- 320006
- 320007
- 320008
- 320009
- 320010
- 320011
- 320013
- 320014
- 320015
- 320017
- 320018
- 320019
- 320020
- 320022
- 320023
Distribution
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