Monarch Platform recall: Software Issue
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Why was Monarch Platform recalled?
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Version 2.2.4
- Product
- Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
- Recalling firm
- AURIS HEALTH INC
- Quantity
- 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.
- Recall date
- December 13, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)