Recall Z-1970-2011 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the COHERENCE RT Therapist, but also cleared under the ONCOR Avante-Garde and Expression, as well as the syngo RT Therapist system, as part of the ARTISTE And PRIMUS system. Manufactured by IMPAC Medical Inc., Sunnyvale, CA, device distributed by Siemens Medical Solutions Oncology Care System, Concord, CA Elec
| Date | Apr 13, 2011 (initiated Aug 21, 2009) |
| Status | Terminated |
| Reason | When editing the note type of a previously entered note, then reverting to the original type, data may be lost. |
| Root cause | Software design |
| Action | Siemens sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to configure their system to lock all new notes automatically. To automatically lock new notes, open eChart Navigator, right mouse click in the notes section, select "configuration" and select "Automatically Lock New Notes." If the customer chooses not to configure their system to automatically lock new notes, follow at least one of the suggestions listed below: If the customer must edit a note |
| Quantity | 30 affected units |
| Distribution | Worldwide Distribution - USA including DE, WI, TX, TN, NJ, PA, NE, MA, and AL and the countries of South Africa, Australia, Ireland, Germany, Brazil, South Korea, India, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031764 | ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES Siemens Medical Solutions USA, Inc., Sep 5, 2003 |
| K060226 | ONCOR EXPRESSION Siemens Medical Solutions USA, Inc., Mar 15, 2006 |
| K072485 | ARTISTE MV SA Siemens Medical Solutions USA, Inc., Dec 27, 2007 |
| K993425 | PRIMUS Siemens Medical Solutions USA, Inc., Nov 26, 1999 |