Z-2983-2011

LANTIS Oncology Information System (OIS) Manufactured by IMPAC/Elekta medical as Multi -Access OIS for...

Name: Z-2983-2011 LANTIS Oncology Information System (OIS) Manufactured by IMPAC/Elekta medical as Multi -Access OIS for...
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-06-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-06-30 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of LANTIS Oncology Information System (OIS) Manufactured by IMPAC/Elekta medical as Multi -Access OIS for Siemens. An oncology digital imaging information... on 2011-06-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2983-2011
Status: Terminated
Initiated: 2011-06-30
Posted: 2011-08-10
Terminated: 2012-03-09
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: 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.
Product code: LMB Device, Digital Image Storage, Radiological
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 59 devices
Distribution: 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.
Product codes and lots: LANTIS Commander. Part Number 4503178; LANTIS system, Part Number 5835991; LANTIS 6.1 Commander, Part Number 5493072; LANTIS 8.3 Commander, Part Number 8148178 Linac Interface, other vendors: Part Number 4504994; LANTIS Varian Clinac, Part Number 1929251; LANTIS GE Saturn, Part Number: 1929277; LANTIS Philips SLS, Part Number 4507203; LANTIS Philips 75 ASU, Part Number 5494120; LANTIC Elekta (Philips), Part Number 5502880; LANTIS Varian EX I/F, Part Number 5846220.

Product code LMB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)