Elekta, Inc.: Laksell Gamma Knife Perfexion

Recall number

Z-0152-2015

Recalling firm

Elekta, Inc.

Product

Laksell Gamma Knife Perfexion

Status

Terminated

Initiated

2014-10-06

Posted

2014-10-30

Terminated

2021-09-15

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 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.

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, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Mexico, Morocco, Netherland, Norway, Poland, Portugal, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.

Lot, serial or model codes

Serial No. 6052, 6144, 6088, 6122, 6158, 6005, 6028, 6097, 6153, 6064, 6081, 6103, 6120, 6143, 6145, 6213, 6215, 6076, 6070, 6136, 6002, 6090, 6131, 6063, 6160, 6077, 6018, 6031, 6040, 6105, 6121, 6013, 6026, 6038, 6050, 6089, 6042, 6055, 6058, 6071, 6080, 6087, 6091, 6096, 9098, 6106, 6108, 6109, 6116, 6118, 6125, 6132, 6133, 6142, 6148, 6149, 6161, 6162, 6175, 6181, 6183, 6198, 6205, 6206, 6163, 6169, 6033, 6041, 6046, 6068, 6113, 6019, 6067, 6110, 6104, 6043, 6044, 6062, 6085, 6086, 6101, 6111, 6123, 6126, 6157, 6177, 6178, 6024, 6069, 6094, 6007, 6075, 6182, 6065, 6159, 6199, 6003, 6017, 6027, 6039, 6112, 6146, 6194, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032, 6034, 6035, 6036, 6037, 6045, 6047, 6048, 6053, 6054, 6056, 6057, 6060, 6061, 6066, 6072, 6073, 6074, 6078, 6079, 6082, 6083, 6084, 6092, 6093, 6095, 6099, 6100, 6102, 6107, 6114, 6115, 6117, 6119, 6124, 6127, 6128, 6129, 6130, 6134, 6135, 6139, 6141, 6150, 6151, 6165, 6167, 6171, 6172, 6173, 6176, 6179, 6180, 6184, 6185, 6191, 6192, 6200, 6203, 6207, 6211

510(k) numbers

["K120811"]

PMA numbers

not on file

Product code

IWB

Firm FEI

1037831

Firm city

Atlanta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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