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Terminated

Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine.

FDA Recall Z-0968-04 · Posted 2004-07-20

Recalling FirmDatex-Ohmeda Inc
Recall StatusTerminated
Product CodeCBN
Date Initiated2004-04-16
Date Terminated2005-11-14
Product Quantity73 units

Reason for Recall

Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.

Firm Action

Recall letters, dated April 26, 2004, stated that a firm representative would contact the consignee to schedule a visit to verify the proper function of each device unit.

Root Cause

Other

Distribution Pattern

The affected units were distributed nationwide in the United States and worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000706DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATORDatex-Ohmeda, Inc. · 2000-05-11

Official Source

View FDA Recall →

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

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