Philips Healthcare Recalls CT Systems Due to Inaccurate Dose Measurements
Philips Healthcare is recalling CT systems because CTDI measurements were 15 to 25% higher than protocol parameters.
What this means for you
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 involves a measurement discrepancy in a medical device without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Healthcare Inc. is recalling certain Computed Tomography (CT) X-Ray Systems. The affected devices include whole-body CT systems or sub-systems with continuously rotating x-ray tubes and multi-row detectors. Specific models include the Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore, Precedence SPECT/CT, Brilliance CT (6, 10, 16, 16P, 40, 64, and Big Bore), Brilliance iCT, and Brilliance iCT SP.
The recall was initiated after Philips Healthcare discovered that a customer performing CTDI measurements for facility accreditation received results that were 15 to 25% higher than the Philips protocol parameters stated. The source text does not specify the total number of units affected, the specific distribution scope, or whether any patients were harmed.
The source text does not provide specific instructions for consumers or healthcare facilities on how to proceed with the recall or remediation.
The recalled product
- Product
- Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at
- Manufacturer
- Philips Healthcare Inc.
- Hazard
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 (18)
- Gemini Dual
- Gemini 16 Power
- Gemini GXL
- Gemini LXL
- Gemini TF 16
- Gemini TF Base/Ready
- Gemini TF 64
- Gemini TF Big Bore
- Precedence SPECT/CT
- Brilliance CT (6
- 10
- 16
- 16P
- 40
- 64
- and Big Bore)
- Brilliance iCT
- Brilliance iCT SP
Distribution
Distributed nationwide across the United States.
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