Skip to content

Oxylog 3000 Plus emergency and transport ventilator recallZ-2018-2023 · Draeger Medical, Inc. · initiated Jun 12, 2023

Class I Open, Classified All recalls posted in July 2023

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Draeger Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.

FDA root cause category: Device Design

What the company is doing

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 [email protected]. 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.

Recall details

Recall number
Z-2018-2023
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Jun 12, 2023
Posted by the FDA
Jul 8, 2023
Recalling firm
Draeger Medical, Inc.
Quantity
300 units
Product code
CBK
FDA submissions
K103625
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.

Product description

Oxylog 3000 Plus emergency and transport ventilator

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

1 device cleared under K103625 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page