Recall Z-2983-2011 ยท LMB Device, Digital Image Storage, Radiological
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 v
| Date | Aug 10, 2011 (initiated Jun 30, 2011) |
| Status | Terminated |
| 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 Zeal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.