Philips Brilliance 64 and Ingenuity CT Systems Software Update Recall
Philips Medical Systems is recalling 42 Brilliance 64 and Ingenuity CT systems to update software and customer release notes.
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 a voluntary precautionary action to update software and documentation, with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 42 Brilliance 64 and Ingenuity Computed Tomography (CT) X-Ray Systems. These devices are whole-body CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
The recall is a field change order released to update software and customer release notes for the affected installed base. The affected units are distributed worldwide, including in the United States and various international countries.
No specific hazards, injuries, or illnesses are reported in the source text. The action is taken to ensure the software and documentation are current for the installed base.
The recalled product
- Product
- Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body 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…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 42
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 64: 728231 & Ingenuity CT: 728326
- 728323. System Code # 728231
- Serial #: 9654
- 91003
- 95130
- 95157
- 95504 System Code # 728326
- Serial #: 32000
- 300003
- 300004
- 300005
- 300010
- 300011
- 300012
- 300014
- 300015
- 300018
- 300027
- 300041
- 300053
Distribution
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