Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Defect
Philips is recalling three Ingenuity Core128 CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.
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 involves a risk-of-harm product where the defect can lead to missing anatomical data, potentially requiring a rescan, but no injuries or illnesses have been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling three units of the Ingenuity Core128 CT system, model number 728323. These computed tomography X-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data.
The recall is due to a software defect that occurs after upgrading to version 3.6.7 via FCO72800643. During the reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue specifically affects gated CT helical reconstruction that is not planned at the iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
The affected units were distributed nationwide in the United States, including the District of Columbia and Puerto Rico. Healthcare facilities should contact Philips Medical Systems for instructions on how to address the software issue and ensure proper image reconstruction.
The recalled product
- Product
- Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 3
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)
- 728323 -- Ingenuity Core128 320004 320053 320056
Distribution
Part of a larger recall action
This product is one of 7 recalled by Philips Medical Systems (Cleveland) Inc 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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