Philips Brilliance iCT SP CT Scanner Recall Due to Bolt Issue
Philips is recalling two Brilliance iCT SP CT scanners because a cooling unit bolt 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 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, which typically indicates a temporary or medically reversible adverse health consequence. The source text describes a mechanical defect (bolt not tightened to specification) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
Philips North America, LLC is recalling two units of the Philips Brilliance iCT SP Computed Tomography X-Ray System, Model # 728311. The recall was initiated because the bolt affixing the cooling unit to the rotor was not tightened to specification.
The affected units were distributed worldwide, including one unit distributed to Iowa. The specific serial numbers identified in the recall are 200044 and 200026.
Healthcare facilities should contact Philips North America, LLC for instructions on how to resolve the issue with the affected equipment.
The recalled product
- Product
- Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
- 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 (1)
- Serial # 200044 Additional unit as off 5/22/20: 200026
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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