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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 Recall
BI70000027 0arm 1000 Imaging System Mobile Xray System
see related information
Date Posted September 26, 2008
Recall Status1 Terminated on December 04, 2008
Recall Number Z-2034-2008
Recall Event ID 49501
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - 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/
Medtronic Navigation, Inc.
300 Foster St
Littleton, Massachusetts 01460-2017
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: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.