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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Navigation Oarm 02

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  Class 2 Device Recall Medtronic Navigation Oarm 02 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-2083-2016
Recall Event ID 74158
510(K)Number K151000  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Medtronic Navigation O-arm 02 surgical x-ray imaging system
Code Information model number BT-700-02000
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		 Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Medtronic planned action to bring device into Compliance: 1. You will contact customers and provide an Errata sheet to them updating the missing and incorrect information. 2. Medtronic field service personnel will perform radiation output measurements via validated procedures to attain compliance with 21CRF part 1020.32(k)(6). 3. You will update the systems software-based instructions for use by a software update which includes the information supplied by the Errata sheet. For questions call (800)-595-9709.
Quantity in Commerce US - 63
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 = OWB and Original Applicant = MEDTRONIC INC.
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