Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine, in a Magnetic Reasonance Suite.
FDA Recall Z-0969-04 · Posted 2004-07-20
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Recalling FirmDatex-Ohmeda Inc
Recall StatusTerminated
Product CodeCBN
Date Initiated2004-04-16
Date Terminated2005-11-14
Product Quantity10 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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