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Class 2 Device Recall Philips Healthcare Ingenuity Elite |
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Date Initiated by Firm |
September 06, 2015 |
Create Date |
June 06, 2016 |
Recall Status1 |
Terminated 3 on March 04, 2021 |
Recall Number |
Z-1719-2016 |
Recall Event ID |
74149 |
510(K)Number |
K033326
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Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product |
Philips Healthcare Ingenuity Elite 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
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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
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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
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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.
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510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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