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Terminated

LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Distributed by Siemens, Concord, CA Mfg by Impac Medical Systems, Sunnyvale, CA Electronic patient records management system

FDA Recall Z-2151-2011 · Posted 2011-05-06

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLMB
Date Initiated2011-03-23
Date Terminated2012-04-19
Product Quantity47

Reason for Recall

There is a potential safety issue in regard to data transfer between LANTIS OIS system and the hospital Information System (HIS) when the HL7 (ADT) interfact is used.

Firm Action

Siemens sent an Urgent Medical Device Correction letter on March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the Safety Advisory Notice in their LANTIS owner manual and contact there Siemens Service Engineer or Application Specialist or contact [email protected]. For questions regarding this recall 925-602-8157.

Root Cause

Other

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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