—#44224

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.

FDA product code: BSZ — Gas-Machine, Anesthesia
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K973985
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: GE Healthcare
Address: 3030 Ohmeda Drive PO Box 7550, zip 53707-7550, Madison, Wisconsin 53718

Distribution

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

Timeline

Recall initiated: 2006-03-22
Posted by FDA: 2006-07-12
Terminated: 2007-05-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #44224. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.