Recall Z-0515-06 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator
| Date | Feb 14, 2006 (initiated Dec 28, 2005) |
| Status | Terminated |
| Reason | Failure to generate an alarm when an unintended disconnection occurrs |
| Root cause | Other |
| Action | Recalling firm has issued a medical device recall letter to consignees to the attention of the Director, Neonatal Intensive Care Unit via Certified Mail to alert them of additional monitoring requirements if a PEEP setting of less than 2.5 mbar is used |
| Quantity | 2261 units |
| Distribution | Product was shipped to medical facilities nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974176 | BABYLOG 8000 PLUS Drager, Inc., Jun 17, 1998 |