MEVATRON KDS,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401522
FDA device recall Z-0157-2008 · posted 2007-11-09 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."
- Action taken
- Distribution of Update Instructions TH007/07/S was sent to all affected sites on March 26, 2007. This was intended to inform users that Service Mode is only for use by authorized personnel, and that unauthorized and/or incorrect softpot parameter changes performed in Service Mode can result in the risk of patient mistreatment. Current control system software versions do not allow unplanned Dosimetry calibration data sets to be erroneously copied during "Service Mode."
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 10 units
- Distribution
- Worldwide:USA including states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Mai
- Date initiated
- 2007-03-22
- Date posted
- 2007-11-09
- Date terminated
- 2010-12-18
- 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 |
|---|---|---|
| MEVATRON, M 2 CLASS (K882729) | Siemens Medical Laboratories, Inc. | 1988-09-19 |