Philips Brilliance CT Scanner Software Recall for Incorrect Tumor Localization
Philips is recalling Brilliance CT scanners with software version 2.0 because a printing error may display incorrect tumor locations, potentially leading to patient mistreatment.
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 medical device defect that may cause mistreatment, which is a risk-of-harm product where specific injury counts are not reported, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling 54 units of Brilliance CT scanners, Big Bore configuration, Model number 728243, equipped with software version 2.0. These devices are intended to provide cross-sectional images of the human body and visualize internal organs.
The recall is due to an anomaly in the software version 2.0 tumor localization application when printing work sheets. This defect causes information regarding the relative locations of marked regions of interest on the patient work sheets to be incorrect. The FDA notes that this error may cause mistreatment of patients.
The affected units were distributed worldwide, including in the US states of California and Nevada. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 54
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)
- Model # 728243 Software Version 2.0
Distribution
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