Philips Ingenuity CT System Recalled for Software Defects
Philips Healthcare is recalling Ingenuity CT systems due to software defects that cause incorrect scan lengths and dose calculations.
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 does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Healthcare is recalling the Ingenuity CT Computed Tomography X-Ray System due to software defects. The recall affects software versions 4.13, 4.14, and 4.15.
The identified defects include shortened sagittal results for axial scans, display errors when creating multi-planner reconstructions, and scan length changes when the field of view is altered. Additionally, the DoseRight algorithm may miscalculate CTDI values, and scan lengths may change during subsequent axial results or near specific lengths of 135mm or 184mm.
The affected units were distributed across numerous US states, including Arizona, Pennsylvania, Florida, and Washington. Healthcare facilities using these systems should contact Philips Healthcare for further instructions on resolving the software issues.
The recalled product
- Product
- Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
- Manufacturer
- Philips Healthcare
- Affected units
- 423
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)
- Software v. 4.13
- 4.14 and 4.15.
Distribution
Part of a larger recall action
This product is one of 7 recalled by Philips Healthcare 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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