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U.S. Department of Health and Human Services

Class 2 Device Recall LANTIS Commander

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  Class 2 Device Recall LANTIS Commander see related information
Date Initiated by Firm March 23, 2011
Date Posted May 06, 2011
Recall Status1 Terminated 3 on April 19, 2012
Recall Number Z-2151-2011
Recall Event ID 58441
Product Classification Device, digital image storage, radiological - Product Code LMB
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
Code Information 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
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact Christine Dunbar
925-602-8157
Manufacturer 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 Determined
Cause 2		 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 Lantis4.healthcare@siemens.com. For questions regarding this recall 925-602-8157.
Quantity in Commerce 47
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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