Recall Z-2018-2023 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
Oxylog 3000 Plus emergency and transport ventilator
| Date | Jul 8, 2023 (initiated Jun 12, 2023) |
| Status | Open, Classified |
| Reason | Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation. |
| Root cause | Device Design |
| Action | The firm initiated recall notification of customers by mail on 06/12/2023. The Urgent Medical Device Recall Notification indicates that customers should make sure that the device's battery is always removed and reinserted/replaced after an occurrence of the "No int. battery charging, " alarm message without removing the device from the main's supply. Prior to the device being used on battery power, the device should be disconnected and reconnected to an AC main supply and verify the color indicators per the provided diagram. Devices may be used safely as long as the provided instructions are f |
| Quantity | 300 units |
| Distribution | Distributed Nationwide. OUS Distribution: Afghanistan, Algeria, Andorra, Angola, Antigua/Barbados, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bolivia, Brunei Dar-es-S, Bulgaria, Burkina-Faso, Cambodia, Canada, Cayman Islands, Chile, China, Christmas Island, Columbia, Congo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103625 | OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE Draeger Medical Systems, Inc., Oct 6, 2011 |