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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Brilliance iCT SP

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  Class 2 Device Recall Philips Healthcare Brilliance iCT SP see related information
Date Initiated by Firm September 06, 2015
Create Date June 06, 2016
Recall Status1 Terminated 3 on March 04, 2021
Recall Number Z-1715-2016
Recall Event ID 74149
510(K)Number K060937  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
Code Information Software v. 4.13, 4.14 and 4.15.
Recalling Firm/
Manufacturer		 Philips Healthcare
3000 Minuteman Rd
Andover MA 01810-1032
Manufacturer Reason
for Recall		 Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Philips plans to initiate a field corrective action that will install a new software release to address the issue. Philips will modify the systems in the field to correct the defect at no cost to the customer. 1. You will contact customers and initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (1-800) 722-9377, Option 5
Quantity in Commerce US-423
Distribution US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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