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U.S. Department of Health and Human Services

Class 2 Device Recall BI70000027 0arm 1000 Imaging System Mobile Xray System

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  Class 2 Device Recall BI70000027 0arm 1000 Imaging System Mobile Xray System see related information
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  
Product Classification Fluoroscopic Image-Intensified X-Ray System - Product Code JAA
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
For Additional Information Contact
978-339-6426
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)
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
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 = JAA and Original Applicant = BREAKAWAY IMAGING, LLC
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