Philips Brilliance iCT Scanner Recall Due to Cracking Cover
Philips is recalling Brilliance iCT scanners because a design change resulted in a thinner plastic cover that may crack.
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, and the source text describes a potential mechanical defect (cracking cover) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling one unit of the Brilliance iCT model #728306. This medical device is intended to produce cross-sectional images of the body.
The recall was initiated because a supplier design change contributed to the use of a thinner plastic for the device cover. This thinner plastic cover may crack.
The affected unit was distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and the United Kingdom. The specific code for the affected unit is 911162.
The recalled product
- Product
- Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.
- 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 (1)
- 911162
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Philips Medical Systems (Cleveland) Inc 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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