Philips CT System Software Recall for Coronary Artery Labeling Defect
Philips is recalling 108 CT systems because a software defect prevents users from labeling coronary arteries in rendered images.
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 defect is a software labeling issue 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 108 units of the Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269. The recall involves specific software versions, including 2.6.1.4, distributed worldwide to the United States and 14 other countries.
The recall was initiated because the software automatically segments coronary arteries in rendered images but fails to extract or highlight the center line when the user hovers over the vessel. This defect makes it impossible to activate the vessel and select the appropriate name from the drop-down menu, preventing correct labeling of the arteries.
The affected units are distributed in the US states of AZ, CA, CO, IL, IN, MA, ME, MI, MO, NC, NJ, NY, OR, TN, TX, VA, and WI, as well as in Austria, Canada, China, France, India, Ireland, Italy, Japan, Netherlands, Norway, Spain, Switzerland, Thailand, and the United Kingdom. Users should contact Philips Medical Systems for further instructions regarding the software defect.
The recalled product
- Product
- Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 108
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)
- Model #728269
- Serial #s: 79906
- 79921
- 79927
- 79937
- 80007
- 80026
- 80031
- 80040
- 80058
- 80062
- 80066
- 80069
- 80087
- 80110
- 80121
- 80155
- 80167
- 80168
- 80169
Distribution
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