Z-0108-2022 Class II Ongoing
FDA device recall Z-0108-2022 was initiated by Draeger Medical, Inc. on September 10, 2021 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 6,797 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 20, 2021
- Initiation Date
- September 10, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,797 units
Product Description
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
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
Distribution Pattern
US Nationwide
Code Information
Software 2.51 and Lower