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U.S. Department of Health and Human Services

Class 2 Device Recall AxiEM" NonInvasive Patient Tracker

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  Class 2 Device Recall AxiEM" NonInvasive Patient Tracker see related information
Date Initiated by Firm December 15, 2022
Date Posted January 30, 2023
Recall Status1 Open3, Classified
Recall Number Z-1039-2023
Recall Event ID 91354
510(K)Number K141833  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product AxiEM" Non-Invasive Patient Tracker
Code Information Product Number/CFN: 9734887XOM UDI-Device Identifier (GTIN/UPN): 00763000588380 Lot Number: 220728I 220729 Product Number/CFN: 9734887XOM UDI-Device Identifier (GTIN/UPN): 00643169608252 Lot Number: 220728I
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact Kyra Nead
303-886-2549
Manufacturer Reason
for Recall		 Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.
FDA Determined
Cause 2		 Process control
Action On 12/15/2022, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via mail courier informing customers is recalling two specific lots of AxiEM Non-Invasive Patient Trackers due to the potential for verification failure of navigation instruments during a Functional Endoscopic Sinus Surgery procedure. Customer are instructed: 1. Do NOT use any impacted product. Immediately locate and quarantine all unused impacted product(s). Refer to the affected lot numbers identified in Table 1 below. 2. Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form. Their Medtronic Sales Representative can assist in initiating the return of the product as necessary. 3. Complete the Customer Confirmation Form enclosed with this letter (even if they have no product to return), acknowledging that they have received this information, and email the completed form to Medtronic at neuro.quality@medtronic.com. 4. If the affected devices have already been utilized and/or discarded, the firm is still asking that customers complete and return the Customer Confirmation Form detailing that information. For questions, contact Medtronic Sales Representative or Medtronic Technical Services at 1-888-826-5603 or via email at rs.navtechsupport@medtronic.com.
Quantity in Commerce 1,867 devies
Distribution Worldwide - U.S. distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The country of Japan.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = MEDTRONIC NAVIGATION, INC.
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