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Terminated

Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator

FDA Recall Z-0515-06 · Posted 2006-02-14

Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2005-12-28
Date Terminated2007-08-07
Product Quantity2261 units

Reason for Recall

Failure to generate an alarm when an unintended disconnection occurrs

Firm 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

Root Cause

Other

Distribution Pattern

Product was shipped to medical facilities nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974176BABYLOG 8000 PLUSDrager, Inc. · 1998-06-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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