Philips Brilliance iCT SP CT Scanner Software Recall
Philips is recalling 57 Brilliance iCT SP CT scanners due to software issues in versions 4.1.3 and 4.1.5 that could affect equipment performance.
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 performance issue without reporting specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 57 units of the Brilliance iCT SP Model No. 728311. The recall is due to software issues found in versions 4.1.3 and 4.1.5 that could affect the performance of the equipment. The product is used to produce cross-sectional images of the body.
The affected units were shipped to 43 U.S. states and numerous countries worldwide. Specific serial numbers are listed in the recall documentation. No specific injuries, illnesses, or deaths are reported in the source text.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issue. Consumers should not use the affected equipment until it has been serviced or replaced according to the manufacturer's guidance.
The recalled product
- Product
- Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — CT Scanner
- Affected units
- 57
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 (20)
- Brilliance iCT SP Model No. 728311 S/N:200107
- 200003
- 200011
- 200009
- 200017
- 200074
- 200022
- 200013
- 200027
- 200049
- 200032
- 200030
- 200043
- 200040
- 200038
- 200047
- 200051
- 200044
- 200063
- 200061
Distribution
Part of a larger recall action
This product is one of 6 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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