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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic 0arm Imaging System

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  Class 2 Device Recall Medtronic 0arm Imaging System see related information
Date Initiated by Firm March 17, 2016
Create Date July 06, 2016
Recall Status1 Terminated 3 on April 06, 2021
Recall Number Z-2082-2016
Recall Event ID 74153
510(K)Number K092564  
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Product Medtronic 0-arm Imaging mobile x-ray system.

Model Numbers - B1-700-00027,
B1-700-00028
Code Information Model No. BI-700-00027 and BT-700-00028
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.-Littleton
300 Foster Street
Littleton MA 01460-2017
For Additional Information Contact
800-595-9709
Manufacturer Reason
for Recall		 It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Medtronic's planned action to bring device into Compliance. 1. You will provide an Errata sheet to customers updating the missing and incorrect information. 2. Field Service Engineers (FSEs) will perform radiation output measurements via validated procedures to attain compliance with 21CFR part 1020.32(k)(6). 3. You will inspect and test X-ray generator and system motion batteries for damage, in accordance with the plan submitted to CDRH. Damaged batteries will be replaced. 4. You will update the systems software-based instructions for use by a software update which includes the information supplied by the Errata sheet. For further questions, please call (800) 595-9709.
Quantity in Commerce US - 581
Distribution Nationwide Distribution
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 = OXO and Original Applicant = MEDTRONIC NAVIGATION, INC. (LITTLETON)
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