Philips Brilliance iCT Recalled for Potential Improper Torque on Rotor Bolt
Philips Medical Systems is recalling a Brilliance iCT unit in Australia because a rotor counterweight bolt may have been improperly torqued.
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 does not report any hospitalizations, injuries, or illnesses. It is a precautionary recall based on documentation review, fitting the Moderate criteria for low-risk or voluntary precautionary actions without reported harm.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling one unit of the Brilliance iCT medical device. The recall was initiated after a retrospective review of production documentation indicated that the M6 Rotor Counterweight Bolt may have been improperly torqued.
The affected unit, identified by Rotor-4535-673-94382 SN 19 and installed on Brilliance ICT System S/N 200203, was distributed in Australia. The source text states that the product was not distributed in the United States.
No specific consumer actions are detailed in the provided source text beyond the identification of the affected unit.
The recalled product
- Product
- Brilliance iCT
- 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)
- Rotor-4535-673-94382 SN 19
- installed on Brilliance ICT System S/N 200203
Distribution
Distribution scope not specified by the agency.
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