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
This recall has been terminated (originally issued May 6, 2011).
- Recall Initiated
- March 23, 2011
- Posted
- May 6, 2011
- Terminated
- April 19, 2012
- Recall Number
- Z-2151-2011
- Quantity
- 47
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
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
Root Cause
Other
Action Taken
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 Lantis4.healthcare@siemens.com. For questions regarding this recall 925-602-8157.