Recall Z-0152-2015 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Laksell Gamma Knife Perfexion
| Date | Oct 30, 2014 (initiated Oct 6, 2014) |
| Status | Terminated |
| Reason | Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame. |
| Root cause | Device Design |
| Action | Elekta sent an" Important Field Safety Notice" distributed on October 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Important Field Safety Notice describes the problem and possible work arounds for customers to follow until a permanent solution can be developed. They are: " Always assure that the plastic lever is only operated when at a right angle with the frame adapter. " Do not force the plastic lever in place if it meets significant resistance when turned. " Ensure that the plastic lever is co |
| Quantity | 181 |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, KY, LA, MA, MI, MN, MS, MO, MT, NJ, NM, NY, NC, OH, OR, PA, RI, SC, TX, TN, UT, VA, WA and WV, and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120811 | LEKSELL GAMMA KNIFE PERFEXION Elekta Instrument AB, May 24, 2012 |