Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
FDA device recall Z-0448-2024 · posted 2023-12-01 · Open, Classified
Recall details
- Recalling firm
- AURIS HEALTH INC
- Reason for recall
- Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- EOQ
- Quantity affected
- 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.
- Date initiated
- 2023-10-18
- Date posted
- 2023-12-01
- Location
- Redwood City, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Monarch Platform (K193534) | Auris Health, Inc. | 2020-04-15 |