LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface
FDA device recall Z-1401-06 · posted 2006-08-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format.
- Action taken
- The firm has issued a safety advisory letter to all affected consignees, and will distribute an updated software version as soon as it is available.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 23 units
- Distribution
- Worldwide Distribution --- USA and countries including Australia, China, Denmark, Germany, New Zealand, Portugal, Russia, Singapore, South Africa, Sweden and Switzerland
- Date initiated
- 2006-07-07
- Date posted
- 2006-08-11
- Date terminated
- 2008-03-26
- Location
- Concord, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEQUENCER (K981313) | Impac Medical Systems, Inc. | 1998-07-09 |