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U.S. Department of Health and Human Services

Class 2 Device Recall Monarch Platform

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  Class 2 Device Recall Monarch Platform see related information
Date Initiated by Firm October 18, 2023
Date Posted December 01, 2023
Recall Status1 Open3, Classified
Recall Number Z-0450-2024
Recall Event ID 93320
510(K)Number K193534  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Code Information Software version 2.2.4
Recalling Firm/
Manufacturer		 AURIS HEALTH INC
150 Shoreline Dr
Redwood City CA 94065-1400
For Additional Information Contact Monarch Support Team
800-434-0032
Manufacturer Reason
for Recall		 Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
FDA Determined
Cause 2		 Software design
Action On October 19, 2023, Auris Health, Inc. issued an "URGENT: MEDICAL DEVICE CORRECTION" notification to affected consignees. Auris asked consignees to take the following actions: Should an image flip be detected in the Virtual Bronchoscope view while navigating toward the target, please perform the following steps to correct the image orientation: 1. Retract the MONARCH Bronchoscope outside the patient 2. Undock the MONARCH Bronchoscope from the arms 3. Clear any fault pop-up messages 4. Re-dock the MONARCH Bronchoscope to the arms 5. Re-initialize Navigation and proceed with the case 6. Please review this letter carefully and share it with anyone in your facility that needs to be informed. 7. Please complete all fields of the attached Acknowledgement Form confirming receipt of this notification and return the form via email to MonarchSupport@its.jnj.com. If you have any questions regarding this letter or need to report any customer complaints, please contact the MONARCH Support team at +1 (800) 434-0032 or via email at MonarchSupport@its.jnj.com.
Quantity in Commerce 110 units In total
Distribution US Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WI & WV.
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 = EOQ and Original Applicant = Auris Health, Inc.
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