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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = OWB
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