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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Brilliance iCT/Brilliance iCT SP running software version 4.1

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 Class 2 Device Recall Philips Healthcare Brilliance iCT/Brilliance iCT SP running software version 4.1see related information
Date Initiated by FirmJuly 31, 2014
Date PostedDecember 16, 2014
Recall Status1 Terminated 3 on February 16, 2017
Recall NumberZ-0236-2015
Recall Event ID 69356
510(K)NumberK060937 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductPhilips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the
Code Information Software version 4.1.
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-659-3000
Manufacturer Reason
for Recall		It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionPhilips Healthcare is directly notifying affected users via letter. In addition, Philips Healthcare has performed the software correction for forward production and plans a Field Correction to fix the defect in the field. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.
Quantity in Commerce16 systems
DistributionUS Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAK
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