Fresh Gas Control (A-FGC1) Unit…

Date posted by the FDA

July 12, 2006

Status

Terminated

Filed by

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.

Reason

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.

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

Quantity

62

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.

Recall started

March 22, 2006

Device type

Gas-Machine, Anesthesia

Root cause (FDA)

Other

What the company told customers

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.

Recall number

Z-1196-06

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1196-06. The agency record governs; check it and the company before acting.