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Class 2 Device Recall BI70000027 0arm 1000 Imaging System Mobile Xray System |
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Date Initiated by Firm |
June 30, 2008 |
Date Posted |
September 26, 2008 |
Recall Status1 |
Terminated 3 on December 04, 2008 |
Recall Number |
Z-2034-2008 |
Recall Event ID |
49501 |
510(K)Number |
K050996
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Product Classification |
Fluoroscopic Image-Intensified X-Ray System - Product Code JAA
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Product |
BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System
Generating 2D and 3D images of human anatomy for surgical applications. |
Code Information |
S/N: 102, 125, 127, 129, 130, 134, 137, 147, 157, and 159. |
Recalling Firm/ Manufacturer |
Medtronic Navigation, Inc. 300 Foster St Littleton MA 01460-2017
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For Additional Information Contact |
978-339-6426
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Manufacturer Reason for Recall |
Failure to of affected units to comply with EER/AKR limits due to misinterpretation of the measurement requirements specified in 21 CFR 1020.32 (d) (3) (iii)
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FDA Determined Cause 2 |
Radiation Control for Health and Safety Act |
Action |
Medtronic Navigation notified service engineers to retest units for compliance. |
Quantity in Commerce |
10 units |
Distribution |
CA, DC, LA, FL. IN, OH, PA, VA |
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 = JAA and Original Applicant = BREAKAWAY IMAGING, LLC
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