Philips Brilliance iCT CT System Recalled for Undocumented Installation
Philips Medical Systems is recalling one Brilliance iCT system because the installation of four M12 bolts was not correctly documented.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low because the issue is a documentation failure regarding installation, which falls under the rubric's criteria for documentation issues and packaging-only problems.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling one Brilliance iCT Computed Tomography X-ray system. The recall is due to a failure to correctly document the installation of four M12 bolts into the system rotor.
The single affected system was distributed in Canada. There was no government or US distribution of this specific unit.
Consumers and healthcare facilities should contact Philips Medical Systems for further instructions regarding the documentation of the installation.
The recalled product
- Product
- Brilliance iCT 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 devices may include signal analysts and display…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 1
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 (2)
- Model Number 728306
- System Serial Number 100619 Rorot-45535-673-94382 SN26
Distribution
Distribution scope not specified by the agency.
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