Devices

Device Recall S/5 Anesthesia Delivery Unit

Model / Serial
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 Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
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 Description
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.
Manufacturer
GE Healthcare
1 Event
- Recall of Device Recall S/5 Anesthesia Delivery Unit

Manufacturer

GE Healthcare

Manufacturer Address
GE Healthcare, 3030 Ohmeda Drive, PO Box 7550, zip 53707-7550, Madison WI 53718
Source
USFDA

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