Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with COHERENCE Therapist
FDA device recall Z-1769-2008 · posted 2008-08-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Software. The firm issued an Advisory Letter Update instruction TH030/07/S as a result of a complaint that images viewed in the device may shift, which could result in mistreatment. The advisory alerts all its affected customers of the image issue to prevent potential mistreatment.
- Action taken
- Customer Safety Advisory Notice was issued on 10/03/2007 to consignees, via certified mail. Consignees are strongly cautioned that they should not further correct the image alignment at this time as doing so will result in incorrect offset values which could lead to incorrect repositioning of the patient. Consignees are instructed to check the "Filter Images on Loading" and "Saving of Filtered Images" config settings, and apply any additional filters to the image BEFORE using the interactive shift or landmark registration tools. Do not correct any perceived issues. A software fix is being validated and will be available soon.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Distribution
- Class II Recall - Worldwide Distribution --- including USA and countries of Angola, Australia, Brazil, Canada, Croatia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Iran, Italy, Japan, Mal
- Date initiated
- 2007-10-03
- Date posted
- 2008-08-20
- Date terminated
- 2011-04-29
- 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 |
|---|---|---|
| ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES (K031764) | Siemens Medical Solutions USA, Inc. | 2003-09-05 |