Oxylog 3000 Plus emergency and transport ventilator
FDA device recall Z-2018-2023 · posted 2023-07-08 · Open, Classified
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
- Action taken
- 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 followed. Customers are to ensure all users and maintenance personnel of affected devices are made aware of this recall. Customers are to return the provided Customer Acknowledgement Card utilizing the printed QR code. A Draeger Service representative will contact customers to arrange a firmware update of the Printed Board Assembly Charger. Any questions regarding the operation of your device are to be made to Service Technical Support at 1-800-437-2437 (press 2, 2, 1). Any questions regarding this recall event are to be directed to Michael Kelhart at 267-664-1131 or mike.kelhart@draeger.com. An updated letter was sent to customers on 02/18/2025 alerting consignees that additional reports of stopped ventilation of devices already updated in which the given alarm No int. battery charging was not handled according to the IFU. As a result of these reports, it was decided to issue an Instructions for Use (IFU) supplement with the check described in the Urgent Medical Device Recall Notice dated June 2023. This IFU was provided with the letter.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- CBK
- Quantity affected
- 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, Bulga
- Date initiated
- 2023-06-12
- Date posted
- 2023-07-08
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE (K103625) | Draeger Medical Systems, Inc. | 2011-10-06 |