Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator
FDA device recall Z-0515-06 · posted 2006-02-14 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- Failure to generate an alarm when an unintended disconnection occurrs
- Action taken
- 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
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 2261 units
- Distribution
- Product was shipped to medical facilities nationwide
- Date initiated
- 2005-12-28
- Date posted
- 2006-02-14
- Date terminated
- 2007-08-07
- Location
- Telford, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BABYLOG 8000 PLUS (K974176) | Drager, Inc. | 1998-06-17 |