Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2151-2011

LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1...

Siemens Medical Solutions USA, Inc. / initiated 2011-03-23 / Terminated

Siemens Medical Solutions USA, Inc began a recall of 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... on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2151-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
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
Product code
LMB Device, Digital Image Storage, Radiological
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.
FDA root cause
Other
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.
Quantity in commerce
47
Distribution
Nationwide Distribution.
Product codes and lots
Model Product Number LANTIS COMMANDER 4503178 LANTIS System 5835991 LANTIS Commander 6.1 5493072 LANTIS 6.1 Complete 8147527 LANTIS 6.1 Essential 8147535 LANTIS 8.3 Complete 8147543 LANTIS 8.3 Essential 8147550 LANTIS 8.3 Commander 8148178