Philips Brilliance iCT SP CT System Recalled for Software Defects
Philips Healthcare is recalling Brilliance iCT SP CT systems due to software defects that cause incorrect scan lengths and dose calculations.
What this means for you
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 software defects lead to incorrect dose calculations and scan parameters, which poses a risk of harm to patients, although no specific injuries are reported in the source text.
Plain-English summary
Philips Healthcare is recalling the Brilliance iCT SP Computed Tomography X-Ray System. The recall is due to software defects in versions 4.13, 4.14, and 4.15 that result in several technical issues, including shortened sagittal results for axial scans, incorrect display of multi-planner reconstructions, and scan length changes when the field of view is altered.
Additionally, the DoseRight algorithm may miscalculate, leading to incorrect CTDI values, and scan lengths may change during subsequent axial results or near specific lengths of 135mm or 184mm. These defects affect the accuracy of the imaging and dose reporting.
The affected systems were distributed in the United States to facilities in Arizona, Pennsylvania, Florida, Washington D.C., West Virginia, North Carolina, South Carolina, Arkansas, Oklahoma, Ohio, New York, Nevada, Texas, Indiana, California, Minnesota, Massachusetts, Mississippi, Maryland, Oregon, Illinois, Colorado, Missouri, Vermont, Iowa, Alabama, Louisiana, Georgia, and Washington. Users should contact Philips Healthcare for instructions on how to resolve these software defects.
The recalled product
- Product
- Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
- Manufacturer
- Philips Healthcare
- Affected units
- 423
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)
- Software v. 4.13
- 4.14 and 4.15.
Distribution
Part of a larger recall action
This product is one of 7 recalled by Philips Healthcare 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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