Recall Z-2018-2023— Draeger Medical, Inc.

Name: FDA recall Z-2018-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-12

Class I · Ongoing

Class I FDA medical device recall by Draeger Medical, Inc., initiated 2023-06-12. It names one FDA 510(k) clearance: K103625. Product: Oxylog 3000 Plus emergency and transport ventilator. Reason: Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation..

Recalling firm: Draeger Medical, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-06-12
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K103625 — OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICEDraeger Medical Systems, Inc.·cleared 2011-10-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Oxylog 3000 Plus emergency and transport ventilator

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.