Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48
FDA device recall Z-1612-2008 · posted 2008-09-23 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 90 units
- Distribution
- Product was distributed throughout the USA (in LA, IN, GA, MD, IL, AR, CA, MA, FL, AZ, SC, MO, CO, AL, OK, WA, MI, IN, NY, TX, MS, NE, TN, VA, WI, OR, DC, and NC) and internationally (Japan, Columbia,
- Date initiated
- 2008-02-13
- Date posted
- 2008-09-23
- Date terminated
- 2011-05-17
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM (K071873) | Varian Medical Systems, Inc. | 2007-08-09 |