Philips Recalls Brilliance Big Bore Oncology CT Scanners Due to Software Errors
Philips Medical Systems is recalling 11 Brilliance Big Bore Oncology CT scanners due to software errors that may affect image generation and display 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 involves a high-risk medical device where software errors may result in the inability to generate CT images or incorrect display settings, posing a risk of harm to patient care, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 11 units of the Brilliance Big Bore Oncology CT scanner, Model # 728243, equipped with software version 4.2.0. The affected devices were distributed worldwide and across the United States.
The recall is due to several software issues. These errors 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, software errors may allow Point of Interest (POI) 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 addresses a request to automatically turn on the center x/y 0 setting and disable result rotation when the CT simulation Exam Card is turned on.
Healthcare facilities using these specific serial numbers should contact Philips Medical Systems for further instructions on resolving the software issues.
The recalled product
- Product
- Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 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
- Category
- Medical Device — CT Scanner
- Affected units
- 11
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)
- Brilliance Big Bore Oncology CT
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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