Terminated

Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Synergy; d. Elekta Infinity; e. Versa HD

FDA Recall Z-0116-2022 · Posted None

Recalling FirmElekta, Inc.

Recall StatusTerminated

Product CodeIYE

Date Initiated2021-09-17

Date Terminated2024-09-30

Product Quantity4,405 units

Reason for Recall

There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.

Firm Action

Written notification letter titled, "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" via email on 09/17/2021. The letter instructs consignees to please post the notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. Consignees are to advise the appropriate personnel, working with this product, on the content of the letter. The consignee is requested to submit an acknowledgement form to their local Elekta representative as soon as possible, but no longer than 30 days from receipt.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed nationwide to FL, NC, OH, CA, IL, MD, OR, AL, NY, PA, MA, AK, GA, OR, KY, VA, TX, SD, AZ, NJ, MI, WI, ND, MO, WA, OK, PR, NM, NC, ID, CT, DE, LA, MT, TN, CO, UT, MN, IN, RI, IA, DC, ND, AZ, HI, KS, NE, NH, AR, WY, WV, MS, VT and internationally to Albania, Antigua/Barbuda, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegowina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kyrgystan, Lao People's Democratic Republic, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestinian Territory, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited · 2021-06-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.