Recall Z-0202-2009 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300.
| Date | Oct 27, 2008 (initiated Oct 3, 2008) |
| Status | Terminated |
| 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 th |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062267 | OXYLOG 3000 Drager Medical B.V., Oct 31, 2006 |