Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.

FDA Recall Z-1787-2012 · Posted 2012-06-17

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeCBK
Date Initiated2012-04-10
Date Terminated2012-07-09
Product Quantity8

Reason for Recall

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

Firm Action

GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 10, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact GE Healthcare Customer or Technical Support at 800-345-2700 for questions regarding this notification.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution - including the states of AL, FL, GA, MO, and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023366DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTSDatex-Ohmeda, Inc. · 2003-10-07

Official Source

View FDA Recall →

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

↑