LANTIS Oncology Information System (OIS) Manufactured by IMPAC/Elekta medical as Multi -Access OIS for Siemens. An oncology digital imaging information management system. Lantis OIS in combination with Sequencer and a non-Siemens linac interface. System components include: LANTIS Commander, LANTIS system, LANTIS 6.1 Commander, LANTIS 8.3 Commander. Subcomponents include: Linac Interface, other vendor, LANTIS Varian Clinac, LANTIS GE Saturn, LANTIS Philips SLS, LANTIS Philips 75 ASU, LANTIS Elekta (Philips) and LANTIS Varian EX I/F.
FDA Recall Z-2983-2011 · Posted 2011-08-10
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLMB
Date Initiated2011-06-30
Date Terminated2012-03-09
Product Quantity59 devices
Reason for Recall
A potential safety issue exists for data transfer between LANTIS OIS system (containing PRIMEVIEW or PRIMEVIEW Data Gateway) and the Sequencer V&R system via a third party interface is used.
Firm Action
Siemens sent an "Update Instructions/Customer Safety Advisory Notice" to all affected users, beginning June 30, 2011.
The letter includes description of the product and problem and provides updated instructions to ensure data is stored in the system.
If you have questions contact Siemens at (925) 602-8157.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution: Nationwide (USA) including the states of MI, DE, WI, FL, CA, TN, NJ, PA, NE, IL, WV , MA and VA; and the countries of Poland, France, Germany, Canada, Netherlands, India, Ireland, Egypt, P.R. china, Australia, Saudi Arabia, Turkey, Republic Korea, Belgium, Hungary, New Zealand, Italy, Malaysia, and Spain.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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