The Recall Desk
HighFDA (Devices)·Z-0109-2022·Announced 2021-10-20

Babylog VN500 Ventilator Firmware Defect May Cause Brief Ventilation Interruption

A software defect in the Babylog VN500 Ventilator may cause it to restart, interrupting ventilation and losing PEEP for about 8 seconds. The issue affects 2,169 units distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with a documented software defect causing ventilator restart and brief ventilation interruption. No illnesses or injuries have been reported, but the hazard poses direct risk to neonatal and pediatric patients dependent on mechanical ventilation.

Plain-English summary

Draeger Medical, Inc. is recalling 2,169 units of the Babylog VN500 Ventilator with Installed CO2 Measurement Option (Catalog Number: 8417400) due to a software defect in version 2.51 and lower.

The defect may cause the ventilator to restart, resulting in a brief cessation of ventilation and loss of PEEP (positive end-expiratory pressure) for approximately 8 seconds. This interruption in ventilation support poses a risk to patients depending on the device for respiratory support.

The affected ventilators are intended for neonatal patients weighing 0.4 kg to 10 kg (0.88 lbs to 22 lbs) and pediatric patients weighing 5 kg to 20 kg (11 lbs to 44 lbs). These units were distributed nationwide.

Healthcare providers and facility managers using this ventilator should contact Draeger Medical, Inc. for information about a firmware update or other corrective measures to address the software defect.

The recalled product

Product
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
Manufacturer
Draeger Medical, Inc.
Category
Medical Device — Respiratory / Ventilator
Hazard
  • device-malfunction
  • software-defect
  • respiratory-interruption

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software 2.51 and Lower

Distribution

Distributed nationwide across the United States.

Related recalls

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