Philips Recalls Brilliance BigBore CT Scanners Due to Image Reconstruction Error
Philips is recalling 67 Brilliance BigBore CT scanners because 4D CT images may be reconstructed at a single phase while incorrectly labeled as specific phases.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a software labeling error with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 67 units of the Brilliance BigBore Radiology CT (model 728244) due to a software issue identified through customer complaints. The defect affects systems running software version 4.2.0 that use the Bellows pulmonary gating device for retrospective respiratory gated 4D CT scans.
The issue causes CT images to be reconstructed at a single phase, while the on-screen annotations incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%). This discrepancy could lead to misinterpretation of the diagnostic images by healthcare professionals.
The affected units were distributed to 22 US states and 17 international countries. Healthcare facilities should contact Philips to arrange for a software update or corrective action. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Brilliance BigBore Radiology CT - 728244 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. These devices may include signal analysts and display…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 67
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 (9)
- System Serial Number - 76001
- 76005
- 76007
- 76009
- 76013
- 76014
- 76017
- 76018
- 76019
Distribution
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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