CLASS II ONGOING Device recall · Reported 20 Oct 2021 · FDA Enforcement Report
Babylog VN500 Ventilator with Installed CO2 Measurement recalled
Draeger Medical is recalling Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the, distributed nationwide in the US. The recall was initiated on 10 Sep 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0109-2022
- FDA event ID
- 88635
- Recalling firm
- Draeger Medical, Telford, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Sep 2021
- FDA classified
- 13 Oct 2021
- Reported
- 20 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 10 Sep 2021 | Recall initiated by company | |
| 13 Oct 2021 | Classified by FDA | +33 days |
| 20 Oct 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Which lots are affected?
Software 2.51 and Lower
Where was it sold?
US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 88635| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Evita V500 Ventilator with Installed CO2 Measurement recalled | Draeger Medical | Device Malfunction | Nationwide |
More recalls from Draeger Medical
All 78| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Atlan A300 recalled by Draeger Medical | Draeger Medical | Device Malfunction | PA |
| Device | CLASS I | Atlan A300XL recalled by Draeger Medical | Draeger Medical | Device Malfunction | PA |
| Device | CLASS I | Atlan A350 recalled by Draeger Medical | Draeger Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Atlan A350XL recalled by Draeger Medical | Draeger Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Dr¿ger Perseus A500 Anesthesia Workstation recalled by Draeger Medical | Draeger Medical | Device Malfunction | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |