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
Reported: October 20, 2021 Initiated: September 17, 2021 #Z-0116-2022
Product Description
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
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.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 4,405 units
- Distribution
- 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.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Elekta, Inc.. Units affected: 4,405 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0116-2022.
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