Elekta, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0152-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Laksell Gamma Knife Perfexion

Product Classification:

Class II

Date Initiated: October 6, 2014

Date Posted: November 5, 2014

Recall Number: Z-0152-2015

Event ID: 69425

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.

Status: Terminated

Product Quantity: 181

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated