Philips Brilliance CT Big Bore Recalled for Radio Frequency Emission Tolerance Issues
Philips is recalling 454 Brilliance CT Big Bore systems because internal testing found radio frequency emissions exceeded IEC 60601-1-2 standards.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling 454 units of the Brilliance CT Big Bore Oncology and Radiology Whole Body Computed Tomography X-Ray Systems. The recall was initiated after internal testing revealed that the devices were out of tolerance for radio frequency emissions.
Specifically, testing at the 48MHz frequency indicated that the Brilliance CT Big Bore emitted signals 3.5dB uV/meter higher than the applicable IEC 60601-1-2 standard specification. The affected units were distributed worldwide, including in the United States and numerous international countries.
No specific consumer actions are detailed in the source text beyond the identification of the defect. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 454
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 Oncology: Model #728243
- Serial #s: 7185
- 7187-7189
- 7191-7199
- 7201
- -7243
- 7245-7251
- 7253-7267
- 7269
- 7270
- 7272-7297
- 7299
- 7300
- 7302
- 7304-7317
- 7319-7374
- 7376-7379
- 7381
- 7382
- 7385
Distribution
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