Skip to content
Recall Observatory FDA recall evidence

Device product

Oxylog 3000 Plus emergency and transport ventilator

Z-2018-2023

June 12, 2023

Class I

Product summary

Firm
Draeger Medical, Inc.
Event
Event 92443
Status
Ongoing
Classification
Class I
Quantity
300 units
Official record key
device-enforcement:Z-2018-2023

Official wording

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

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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