Z-1196-06

Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery...

Name: Z-1196-06 Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery...
Creator: GE Healthcare
Published: 2006-03-22
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-03-22 / Terminated

FDA source

GE Healthcare began a recall of 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... on 2006-03-22. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1196-06
Status: Terminated
Initiated: 2006-03-22
Posted: 2006-07-12
Terminated: 2007-05-29
Recalling firm: GE Healthcare
Product: 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.
Product code: BSZ Gas-Machine, Anesthesia
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.
FDA root cause: Other
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.
Quantity in commerce: 62
Distribution: 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
Product codes and lots: S/5 Anesthesia Delivery Unit serial numbers: 6028818, 6048768, 6048777, 6048778, 6048795, 6048797, 6048799, 6048808, 6048811, 6048812, 6048815, 6048827, 6067704, 6067706, 6085914, 6085926, 6085927, 6085929, 6085935, 6085937, 6086576, 6086577, 6086583, 6086585, 6086588, 6086589, 6086592, 6086593, 6086595, 6086596, 6086600, 6086601, 6086602, 6086603, 6086608, 6086610, 6086611, 6086612, 6086613, 6097355, 6097356, 6097357, 6097364. A-FGC1 Units serial numbers: 6020250, 6044947, 6044950, 6044951, 6045113, 6045120, 6045122, 6045127, 6045138, 6045151, 40022777, 40100065, 40106020, 40114446, 40115565, 40119019, 40121119, 40149506, 40173259.

Product code BSZ

K973985Class IIAs/3 Anaesthesia Delivery Unit (As/3 Adu)Datex-Engstrom, Inc. / cleared 1998-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)