Draeger Medical, Inc. Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300.
Brand
Draeger Medical, Inc.
Lot Codes / Batch Numbers
Serial numbers SRZA-0182 and higher tahn 0182, SRZB-xxxx, SRZC-xxxx, SRZD-xxxx, SRZE-xxxx, SRZF-xxxx, SRZH-xxxx, and SRZJ-xxxx. Note that xxxx stands for numbers 0001 through 9999.
Products Sold
Serial numbers SRZA-0182 and higher tahn 0182, SRZB-xxxx, SRZC-xxxx, SRZD-xxxx, SRZE-xxxx, SRZF-xxxx, SRZH-xxxx, and SRZJ-xxxx. Note that xxxx stands for numbers 0001 through 9999.
Draeger Medical, Inc. is recalling Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre- due to May experience an interruption of ventilation for approximately 5 seconds. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
May experience an interruption of ventilation for approximately 5 seconds
Recommended Action
Per FDA guidance
The firm issued an Urgent - Medical Device Recall letter dated September 2008. Software version 1.10 may under specific conditions experience an interruption of ventilation for approximately 5 seconds. During that time period, the patient airway pressure may drop to zero. This phenomenon was identified by Draeger engineers and to date has not been reported by any user. The firm's investigations revealed that when ventilating in BIPAP mode with the pressure rise time (Ramp) set to the highest setting and the expiration time set to exactly 0.5 seconds, the inspiration phase can coincide with the internal auto zero function of the device. Under these circumstances a pressure spike will occur upon reaching Pmax +5mbar (cmH2O) which with software version 1.10 will lead to the inspiratory phase stopping. Ventilation will resume after approximately 5 seconds. The device will generate a Paw Measurement INOP alarm. Until the new software is available, customers are being instructed to avoid the use of the following combination of settings: 1) BIPAP mode; 2) Ramp = highest, and 3) Texp = 0.5 seconds.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026