Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and including v7.3.10 SP2 (used with Br
FDA device recall Z-0393-06 · posted 2006-01-18 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- Reason for recall
- The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment.
- Action taken
- On 11/23/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
- Root cause
- Other
- Status
- Terminated
- Product code
- IWB
- Distribution
- Worldwide to 219 accounts. U.S. States: AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV. 118 accounts For
- Date initiated
- 2005-11-23
- Date posted
- 2006-01-18
- Date terminated
- 2006-07-05
- 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 |
|---|---|---|
| ACUITY RADIATION THERAPY SIMULATOR (K023052) | Varian Medical Systems, Inc. | 2002-10-11 |
| ECLIPSE 6.5 (K010975) | Varian Medical Systems, Inc. | 2001-05-02 |
| VARIAN ORIGAMI, VERSION 1.0 (K932501) | Varian Assoc., Inc. | 1994-09-23 |