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Class 2 Device Recall THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2 |
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Date Initiated by Firm |
May 23, 2018 |
Create Date |
August 22, 2018 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2889-2018 |
Recall Event ID |
80769 |
510(K)Number |
K133875
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Product Classification |
System, image processing, radiological - Product Code LLZ
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Product |
Vertebral Motion Analyzer (VMA), 2.3.250.
Product System, image processing, radiological |
Code Information |
00868579000209 |
Recalling Firm/ Manufacturer |
Ortho Kinematics, Inc 110 Wild Basin Rd Ste 250 West Lake Hills TX 78746-3352
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For Additional Information Contact |
512-334-5490
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Manufacturer Reason for Recall |
This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.
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FDA Determined Cause 2 |
Software design |
Action |
Ortho Kinematics notified customers via Email and notification through web app with a notification dated December 6, 2016. The notification contained the following information: reason for correction, report information, and required action for acknowledgement. |
Quantity in Commerce |
1 |
Distribution |
U.S. Nationwide Distribution |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = ORTHO KINEMATICS, INC.
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