Philips Brilliance Big Bore CT Software Recall for Image Generation Errors
Philips is recalling 119 Brilliance Big Bore CT scanners due to software errors that may prevent image generation or display incorrect settings.
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 rubric assigns a score of 3 (High) to risk-of-harm products where injury has not yet been reported, as no specific injuries or illnesses are mentioned in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 119 units of the Brilliance Big Bore Radiology CT with 4.2.0 software version. The devices are distributed worldwide and across the United States. The recall addresses specific software errors that may result in the Extended Field of View check message not being displayed when the Field of View is set greater than 600 mm for a paused scan. Additionally, the software may allow Point of Interest locking when a non-isocenter slice is displayed, or result in a partial set of images or an inability to generate CT images.
The recall also involves a request to change the software to automatically turn on the center x/y 0 setting and disable the result rotation setting when turning on the CT simulation Exam Card. These issues affect the reliability of the imaging process and the display of safety checks. The specific serial numbers for the affected units are listed in the agency's recall record.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve these software issues. The recall is classified as Class II by the FDA, indicating that the use of the product may cause temporary or medically reversible health consequences, or that the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 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
- 119
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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