Philips Brilliance 64 CT Scanner Software Defect Recall
Philips is recalling 291 Brilliance 64 CT scanners because a software defect prevents Surview scans from initializing when tube current is below 30 mA.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which falls under the 'High' severity category in the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 291 units of the Brilliance 64 Computed Tomography (CT) scanner, model number 728231, equipped with software version 4.1.7 XX026. The recall is due to a software defect that prevents Surview scans from initializing when the tube current is set lower than 30 mA.
The affected devices were distributed worldwide, including in the United States (specifically in Georgia, Virginia, Michigan, and Arizona) and in Canada and Switzerland. Specific serial numbers for the affected units are 9134, 9667, 9738, 9788, 9923, 10773, 95263, and 95669.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issue. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: 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. These…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 291
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 (1)
- Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669
Distribution
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