Philips CT System Recalled for Software Defects Affecting Scan Accuracy
Philips Healthcare is recalling Ingenuity Elite CT systems due to software defects that cause incorrect scan lengths and dose calculations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 explicitly states no illnesses or injuries are reported, and the defects are software-related without immediate physical harm, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Healthcare is recalling the Ingenuity Elite Computed Tomography X-Ray System in the United States. The recall involves 423 units distributed across 31 states and the District of Columbia. The affected systems are running software versions 4.13, 4.14, or 4.15.
The recall is due to software defects that result in several issues, including shortened sagittal results for axial scans, incorrect display of multi-planner reconstructions, and changes in scan length when the field of view is adjusted. Additionally, the DoseRight algorithm may miscalculate CTDI values, leading to incorrect dose reporting, and scan lengths may change during subsequent axial results or near specific lengths of 135mm or 184mm.
Healthcare facilities using these systems should contact Philips Healthcare for instructions on how to resolve the software defects. The source text does not report any illnesses or injuries associated with these defects.
The recalled product
- Product
- Philips Healthcare Ingenuity Elite 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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