Laksell Gamma Knife Perfexion

FDA device recall Z-0152-2015 · posted 2014-10-30 · Terminated

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.

Action taken

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 completely flush with the frame adapter and that no angulations are present. Corrective Action #2 - Elekta will check and replace as necessary affected frame adapters in the field. This will be released at the end of October 2014, and Elekta will have six months to complete the checks and replacements for those products in the field. If you have any questions please contact your local Elekta office, or call (770) 300-9725.

Root cause

Device Design

Status

Terminated

Product code

IWB

Quantity affected

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,

Date initiated

2014-10-06

Date posted

2014-10-30

Date terminated

2021-09-15

Location

Atlanta, GA

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