Recall Z-2690-2024 ยท NOU Continuous, Ventilator, Home Use
Breas Medical, Inc.
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
| Date | Sep 3, 2024 (initiated Jul 25, 2024) |
| Status | Open, Classified |
| Reason | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions. |
| Root cause | Under Investigation by firm |
| Action | On August 5, 2024, URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Actions to be taken by Customer / User: 1. Since the elevated levels of formaldehyde were observed with the Vivo 45 LS operated at higher room temperatures, 40C (104F), as a matter of precaution, Breas Medical is lowering the maximum room air temperature for operation of the device from 40C (104F) to 30C (86F). 2. The following additional measure applies to new Vivo 45 LS devices distributed on or before July 24, 2024, that have not been in use for at least 14 days: Pre-run the device for at least 14 days in |
| Quantity | 8298 |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193586 | Vivo 45 LS Breas Medical AB, Jan 27, 2021 |