United StatesLeksell Gamma Knife radiosurgery systems (models Perfexion, Icon, and Elekta Esprit) are affected; units include those identified under Lot Code 07340048303019 and multiple listed product and serial numbers. The devices were recalled because an adapter may not be properly aligned or locked in place.
What's being recalled
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
Recalling firm: Elekta, Inc., Atlanta, GA, United States.
How to identify it
Lot Code: 07340048303019 (Perfexion) Product and Serial Numbers: LGK Perfexion/11868-004/6002 LGK Perfexion/12214-003/6007 LGK Perfexion/10567-026/6011 LGK Perfexion/10567-024/6014 LGK Perfexion/12451-001/6019 LGK Perfexion/10064-008/6021 LGK Perfexion/18630-001/6031 LGK Perfexion/11813-003/6034 LGK Perfexion/11007-005/6035 LGK Perfexion/10908-003/6045 LGK Perfexion/13337-LGK001/6052 LGK Perfexion/10762-005/6057 LGK Perfexion/11550-001/6065 LGK Perfexion/14878-003/6067 LGK Perfexion/11792-005/6077 LGK Perfexion/10356-007/6079 LGK Perfexion/10924-001/6089 LGK Perfexion/15045-LGK001/6091 LGK Perfexion/11848-003/6095 LGK Perfexion/12236-006/6097 LGK Perfexion/13558-001/6099 LGK Perfexion/20364-001/6103 LGK Perfexion/10848-LGK001/6108 LGK Perfexion/11390-LGK001/6109 LGK Perfexion/30002718-001/6113 LGK Perfexion/11433-LGK001/6116 LGK Perfexion/10643-005/6117 LGK Perfexion/11990-LGK001/6118 LGK Perfexion/12620-002/6120 LGK Perfexion/17322-001/6121 LGK Perfexion/105528-001/6122 LGK Perfexion/11999-001/6126 LGK Perfexion/10917-004/6128 LGK Perfexion/17357-001/6130 LGK Perfexion/10394-LGK01/6144 LGK Perfexion/30002934-ENS/6160 LGK Perfexion/10583-LGK002/6161 LGK Perfexion/16867-001/6166 LGK Perfexion/10929-LGK002/6175 LGK Perfexion/10424-001/6182 LGK Perfexion/17539-001/6185 LGK Perfexion/11377-003/6186 LGK Perfexion/16647-001/6187 LGK Perfexion/11733-001/6192 LGK Perfexion/10960-005/6193 LGK Perfexion/21061-001/6195 LGK Perfexion/11439-002/6196 LGK Perfexion/30000655-001/6199 LGK Perfexion/11731-005/6200 LGK Perfexion/11149-LGK002/6206 LGK Perfexion/11077-007/6207 LGK Perfexion/30001910-001/6208 LGK Perfexion/13514-001/6211 LGK Perfexion/10979-002/6213 LGK Perfexion/10208-003/6215 LGK Perfexion/11127-009/6219 LGK Perfexion/30000732-001/6223 LGK Perfexion/30001270-001/6225 LGK Perfexion/11420-001/6228 LGK Perfexion/30001527-001/6231 LGK Perfexion/10879-LGK002/6234 LGK Perfexion/10698-001/6237 LGK Perfexion/10711-002/6243 LGK Perfexion/10148-LGK002/6245 LGK…
The hazard
Due to adapter not being properly aligned or locked in place.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)