Devices

Device Recall EasyLink(TM) Informatics Systems

Model / Serial
Catalog number 1000034805
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- USA (nationwide) and the countries of CANADA, FRANCE, GERMANY, SPAIN, PORTUGAL, ITALY, JAPAN, NORWAY, AUSTRALIA, AUSTRIA, NEW ZEALAND, BELGIUM, SWITZERLAND, NETHERLANDS, MALAYASIA, SLOVENIA, SOUTH KOREA, DENMARK, SAUDI ARABIA, SLOVAKIA, PUERTO RICO, INDONESIA and TAIWAN.
Product Description
EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. || The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System, and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. || Product Quantity Distributed (Int) 787
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of Device Recall EasyLink(TM) Informatics Systems

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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