Draeger Medical, Inc.: Oxylog 3000 Plus emergency and transport ventilator

Recall number

Z-2018-2023

Recalling firm

Draeger Medical, Inc.

Product

Oxylog 3000 Plus emergency and transport ventilator

Status

Open, Classified

Initiated

2023-06-12

Posted

2023-07-08

Terminated

not on file

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 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.

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, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Faeroe, Finland, France, French Polynesia, French Guiana, Gabon, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Laos, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Macau, Malawi, Malaysia, Mali, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, North Korea, Norway, Oman, Pakistan, Panama, Pap. New Guinea, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Rwanda, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Sint Maarten, Slovenia, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Kingdom, Uruguay, Utd. Arab. Emirates, Uzbekistan, Vietnam, Yemen, Zambia, and Zimbabwe.

Lot, serial or model codes

Catalog No. 5704811 & 5704813; UDI-DI: 04048675398295; All Serial No.

510(k) numbers

["K103625"]

PMA numbers

not on file

Product code

CBK

Firm FEI

2517967

Firm city

Telford

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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