openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This m
These labels are deterministic app interpretations, not FDA categories.
GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time. This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. This m
Code information
Serial Number AMRP01031 AMRP00966 AMRP01030 AMRP00968 AMRP00967 AMRP01033 AMRP00970 AMRP00969
Distribution pattern
Nationwide Distribution - including the states of AL, FL, GA, MO, and VA.
