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

• Date Initiated by Firm: June 30, 2008
• Date Posted: September 26, 2008
• Recall Status: Terminated 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.
• FEI Number: 3004785967
• 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: 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