Philips CT Scanners Recalled for Image Artifacts Impairing Diagnostic Quality
Philips is recalling Brilliance CT 64 and Ingenuity Core scanners due to software issues causing image artifacts that may impair diagnostic quality.
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 the hazard involves a risk of harm (impaired diagnostic quality) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling specific models of Computed Tomography (CT) X-ray systems, including the Brilliance CT 64, Ingenuity Core, and Ingenuity Core128. The recall involves 2,348 total units distributed nationwide in the United States.
The recall was initiated after Philips Healthcare received field reports that certain systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts on reconstructed images. These artifacts may impair the diagnostic quality of the affected images, potentially affecting the accuracy of medical diagnoses.
Healthcare facilities and users of these specific CT scanner models should contact Philips Medical Systems to verify if their equipment is affected and to arrange for the necessary corrective actions. The affected units are identified by specific system code numbers and serial numbers listed in the official recall documentation.
The recalled product
- Product
- Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
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 (20)
- Serial #: 4001
- 4003
- 4016
- 4020
- 9009
- 9029
- 9030
- 9033
- 9034
- 9037
- 9038
- 9040
- 9041
- 9043
- 9044
- 9045
- 9048
- 9049
- 9051
- 9052
Distribution
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