Philips Brilliance iCT SP CT Systems Recalled for Software Error
Philips is recalling 49 Brilliance iCT SP CT systems due to a software error that may prevent automatic transmission of image data to remote devices.
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. The hazard involves a software error affecting data transmission, which is a functional defect without reported injuries or immediate physical harm, fitting the criteria for a moderate severity recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 49 units of the Brilliance iCT SP Computed Tomography X-ray Systems. These systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
The recall was initiated after the firm was notified of a software error. This error may cause the system to fail to automatically send all image and data series to remote devices.
The affected units were distributed worldwide, including in the United States and numerous international countries. The specific model number is 728311, and the affected serial numbers range from 200011 to 200211. Users of these systems should contact Philips Medical Systems for further instructions regarding the software issue.
The recalled product
- Product
- Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 49
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)
- Model No. 728311
- S/N: 200011
- 200013
- 200017
- 200022
- 200027
- 200030
- 200032
- 200038
- 200040
- 200047
- 200049
- 200051
- 200061
- 200063
- 200067
- 200068
- 200074
- 200088
- 200093
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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