FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: 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.
- Recall number
- Z-2983-2011
- 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.
- Status
- Terminated
- Initiated
- 2011-06-30
- Posted
- 2011-08-10
- Terminated
- 2012-03-09
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LMB
- Firm FEI
- 2937457
- Firm city
- Concord
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28