Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Reported: June 9, 2021 Initiated: April 16, 2021 #Z-1691-2021
Product Description
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Reason for Recall
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
Details
- Recalling Firm
- Draeger Medical, Inc.
- Units Affected
- 18 units
- Distribution
- US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.. Recalled by Draeger Medical, Inc.. Units affected: 18 units.
Why was this product recalled? ▼
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 9, 2021. Severity: Moderate. Recall number: Z-1691-2021.
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