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)
Reported: September 11, 2024 Initiated: July 25, 2024 #Z-2690-2024
Product Description
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)
Reason for Recall
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.
Details
- Recalling Firm
- Breas Medical, Inc.
- Units Affected
- 8298
- Distribution
- US Nationwide.
- Location
- North Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Breas Medical, Inc.. Units affected: 8298.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 11, 2024. Severity: Critical. Recall number: Z-2690-2024.
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