Philips Brilliance BigBore CT Systems Recalled for Software Defect
Philips is recalling eight Brilliance BigBore Oncology CT systems due to a software defect causing intermittently slow response of the Host.
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 source text describes a software defect causing slow response without reporting any injuries, illnesses, or specific safety hazards like radiation exposure or mechanical failure. This aligns with a moderate severity for a functional defect in a medical device where no immediate harm is documented.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling eight units of the Brilliance BigBore Oncology Computed Tomography X-ray system. These systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
The recall is due to a software defect that causes intermittently slow response of the Host. The affected units are identified by Model # 728243 and specific serial numbers: 7063, 7116, 7169, 7205, 7309, 7314, 7354, and 7611.
The product was distributed to numerous states in the United States and various countries internationally. Healthcare facilities should contact Philips Medical Systems for instructions on how to address the software defect.
The recalled product
- Product
- Brilliance BigBore Oncology 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.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 8
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)
- Model #: 728243
- Serial #s: 7063
- 7116
- 7169
- 7205
- 7309
- 7314
- 7354
- 7611.
Distribution
Part of a larger recall action
This product is one of 7 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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