FDAFDA · Food and drugs·Recall number Z-0152-2015
Laksell Gamma Knife Perfexion
Published November 5, 2014 · Recall initiated: October 6, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- 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 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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