Reported Jun 9, 2021 · Terminated
Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who…
Draeger Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Draeger Medical, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042
Is this the product you have?
- Critical Care Ventilator
- Catalog Number(s)8422200:
- Babylog VN600 - Product Usageused for treating patients who require temporary or longer term respiratory support for different medical reasons
- Lot codes and dates
- All lots/serial numbers manufactured from 1/1/2019-3/31201
- Amount recalled
- 2 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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