Terminated

Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and including v7.3.10 SP2 (used with BrainLab M3 MultiLeaf Collimator (MLC); Eclipse (used with BrainLab M3 MLC); Acuity (used with BrainLab M3 MLC); Product Number 83 (used with Product Number 53); Product Number 48 (used with Product Number 53); Product Number 77 (used with Product Number 53); Product is distributed by Varian Medical Systems, 911 Hansen Way, Palo Alto, CA 94304

FDA Recall Z-0393-06 · Posted 2006-01-18

Recalling FirmVarian Medical Systems Inc

Recall StatusTerminated

Product CodeIWB

Date Initiated2005-11-23

Date Terminated2006-07-05

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.

Firm Action

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

Distribution Pattern

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 Foreign consignees include Netherlands, Thailand, Taiwan, R.O.C., Sweden, Spain, South Korea, South Africa, Slovenia, Singapore, Saudi Arabia, Russian Fed., Portugal, Poland, Philippines, Mexico, Malaysia, Japan, Italy, Israel, India, Hong Kong, Germany, France, Finland, Egypt, Denmark, Czech Republic, China, Canada, Brazil, Belgium, Austria, and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023052ACUITY RADIATION THERAPY SIMULATORVarian Medical Systems, Inc. · 2002-10-11 K010975ECLIPSE 6.5Varian Medical Systems, Inc. · 2001-05-02 K932501VARIAN ORIGAMI, VERSION 1.0Varian Assoc., Inc. · 1994-09-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.