Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Defect
Philips is recalling 30 Ingenuity Core CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scans.
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. The hazard involves a risk of harm (missed diagnosis due to missing anatomy) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 30 units of the Ingenuity Core, Model number 728321, Computed Tomography (CT) X-ray systems. These devices 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 identified 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 occurs on 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. The specific serial numbers affected are listed in the agency's recall record. Healthcare facilities should contact the manufacturer for further instructions regarding the software issue.
The recalled product
- Product
- Ingenuity Core, Model number 728321 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
- 30
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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