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Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz… recallZ-0449-2024 · Auris Health Inc · initiated Oct 18, 2023

Class II Open, Classified All recalls posted in December 2023

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Auris Health Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.

FDA root cause category: Software design

What the company is doing

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 [email protected]. 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 [email protected].

Recall details

Recall number
Z-0449-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Oct 18, 2023
Posted by the FDA
Dec 1, 2023
Recalling firm
Auris Health Inc
Quantity
110 units In total
Product code
EOQ
FDA submissions
K193534
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.

Product description

Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w

Code information (models, lots, serial numbers)

Software version 2.2.4

Other devices under the same FDA submission

1 device cleared under K193534 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93320).

Sources and updates

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