Devices

Device Recall Acuson/Sonovista X300

Model / Serial
Sonovista: 10133170 (Japan only) Acuson: 10037409 (potentially affected but no volume: 10132987, 10038837). Software revisions 1.0.06 and 1.0.07 for Sonovista X300 and 1.0.08 for Acuson X300
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: USA, Singapore, Germany, Denmark, Romania, Sweden, Poland, Portugal, Australia, Chile, India, Spain, Thailand, Malaysia, South Africa, Hungary, Saudi Arabia, Qatar, Peru, Italy, Azerbaijan, Greenland, Austria, Venezuela, Puerto Rico, Brazil and Japan.
Product Description
Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista X300 software revision 1.0.06 and 1.0.07, Acuson X300 sofware revision 1.0.08 ultrasound system with onscreen display.
Manufacturer
Siemens Medical Solutions USA, Inc.
1 Event
- Recall of Device Recall Acuson/Sonovista X300

Manufacturer

Siemens Medical Solutions USA, Inc.

Manufacturer Address
Siemens Medical Solutions USA, Inc., 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94039-7393
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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