Philips Brilliance IQon Spectral CT Recall for Cooling Unit Bolt Issue
Philips is recalling two Brilliance IQon Spectral CT systems because a bolt on the cooling unit was not tightened to specification.
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, and the hazard involves a structural component (bolt) on a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Philips North America, LLC is recalling two units of the Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System (Model # 728332). The recall involves serial numbers 860067 and 860023. The agency classifies this as a Class II recall.
The recall is being issued because the bolt affixing the cooling unit to the rotor was not tightened to specification on the affected systems. The source text does not report any specific injuries, illnesses, or malfunctions resulting from this defect.
The affected units were distributed worldwide, including one unit distributed to Iowa. The source text does not provide specific instructions for consumers or healthcare facilities on how to proceed with the recall.
The recalled product
- Product
- Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 2
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)
- Serial #s 860067
- 860023
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Philips North America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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