Philips Healthcare Ingenuity Core128 CT System Software Defect Recall
Philips Healthcare is recalling 423 Ingenuity Core128 CT systems in the US 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 3/5 (High).
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 involves a risk-of-harm product (medical device) where the software defects could lead to incorrect patient data or dose reporting, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Healthcare is recalling 423 units of the Ingenuity Core128 Computed Tomography X-Ray System in the United States. The recall is due to software defects in versions 4.13, 4.14, and 4.15 that affect the accuracy of scan data and dose reporting.
The identified software defects 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.
The affected systems are distributed across 31 states and the District of Columbia, including Arizona, Pennsylvania, Florida, and Texas. The FDA has classified this as a Class II recall. Healthcare facilities should contact Philips Healthcare for instructions on correcting the software defects.
The recalled product
- Product
- Philips Healthcare Ingenuity Core128 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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