Philips Brilliance CT Scanners Recalled for Software Data Flipping Error
Philips is recalling Brilliance CT scanners because a software anomaly causes Intensity Projection datasets to be flipped and incorrectly labeled left-to-right.
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 product (medical imaging data integrity) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 765 units of Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore (Model #728243) and Big Bore Oncology (Model #728244). The recall involves specific serial numbers distributed worldwide, including the United States and Canada.
The recall was initiated due to a software anomaly in the TumorLOC program. The software can generate Intensity Projection data sets from respiratory gated data, but a circumstance was identified where these generated datasets are 'flipped' and incorrectly labeled left-to-right when saved to disk. This error could result in incorrect data orientation for medical imaging.
Affected units are located in hospitals and medical facilities. Healthcare providers should contact Philips Medical Systems for instructions on how to resolve the software issue. No specific consumer action is required for the general public, as these are professional medical devices.
The recalled product
- Product
- Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — CT Scanner
- Affected units
- 765
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)
- Brilliance CT Big Bore - Model #728243 - Serial Numbers: 7006
- 7007
- 7008
- 7009
- 7013
- 7014
- 7015
- 7016
- 7017
- 7018
- 7019
- 7020
- 7021
- 7022
- 7023
- 7024
- 7025
- 7026
- 7027
- 7028
Distribution
Part of a larger recall action
This product is one of 4 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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