FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300.
- Recall number
- Z-0202-2009
- Recalling firm
- Draeger Medical, Inc.
- Product
- Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300.
- Status
- Terminated
- Initiated
- 2008-10-03
- Posted
- 2008-10-27
- Terminated
- 2009-10-16
- Reason
- May experience an interruption of ventilation for approximately 5 seconds
- Root cause
- Software design
- Action
- 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.
- Quantity
- 50 units
- Distribution
- Nationwide Distribution --- including states of AZ, CA, FL, IL, IN, KY, LA, ME, MI, MO, NC, NE, NJ, NY, OH, PA, TX, UT, VT, WA, WV, and WY.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K062267"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2517967
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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