Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery Unit is designed to mix and dose respiratory gases and to ventilate the patient. The delivery unit is the basis for a flexible anesthesia system with full monitoring and data management capabilities.
FDA Recall Z-1196-06 · Posted 2006-07-12
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeBSZ
Date Initiated2006-03-22
Date Terminated2007-05-29
Product Quantity62
Reason for Recall
There exists the possibility that the ADU Fresh Gas Control unit (A-FGC1) can shut off during normal handling of the anesthesia machine and result in no anesthetic agent output.
Firm Action
An Urgent Medical Device Correction letter dated March 21, 2006, was sent to customers. It warns of the potential for no anesthetic agent output. The letter contains short term recommendations for use of the device until a GE Healthcare representative contacts the facility to schedule a vist and implelment corrective action.
Root Cause
Other
Distribution Pattern
World wide-(including the States of IA, CA, MI, FL, MI, TX, IL, WI, OH, and countries of Finland, Singapore, Austria, South Africa, Sweden, Israel, Norway, Taiwan, Germany, Turkey, Portugal, Italy, Switzerland, Great Britain, and France
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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