Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekt
Summary
The FDA issued a Class II for Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Pr by Elekta, Inc.. Reason: 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 surrou.
Details
Source
Device Recall
External ID
Z-0116-2022
Action Date
2021-10-20
Status
Terminated
Category
device
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
Lot/Code Info: a. Elekta Precise Digital Accelerator - UDI GTIN Number: 5060191071017, Model Numbers: XRT 0601 (NFB), XRT 0611 (FB), All Serial Numbers; b. Elekta Harmony - UDI GTIN Number: 05060191071581, Model Numbers: XRT 2201 (NFB), All Serial Numbers; c. Elekta Synergy - UDI GTIN Number: 05060191071550, Model Numbers: XRT 0621 (NFB), XRT 0631 (FB), All Serial Numbers; d. Elekta Infinity - UDI GTIN Number: 05060191071543, 05060191071512, Model Numbers: XRT 0511 (NFB & MLCi2), XRT 0521 (FB & MLCi2), XRT 0531 (NFB & Agility), XRT 0541 (FB & Agility), All Serial Numbers; e. Versa HD - UDI GTIN Number: 05060191071574, 05060191071529, Model Numbers: XRT 2121 (NFB), XRT 2131 (FB), All Serial Numbers
Quantity Affected: 4,405 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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-17
Company
Atlanta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 174 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Elekta, Inc. has 24 FDA actions in our database, including 24 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Elekta, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Elekta, Inc. have FDA actions?
Elekta, Inc. has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0116-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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