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Open, Classified

Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy

FDA Recall Z-1665-2023 · Posted 2023-05-30

Recalling FirmElekta, Inc.
Recall StatusOpen, Classified
Product CodeIYE
Date Initiated2023-05-05
Product Quantity46 units

Reason for Recall

A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601

Firm Action

Elekta notified customers, via email, on 05/05/2023. Customers were instructed that Elekta will contact each impacted customer to perform an onsite inspection of the power supply unit and replace as needed. Customers were asked to complete and return the Acknowledgement Form.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA. International distribution to Belgium, Canada, Chile, China, France, Germany, India, Iraq, Italy, Jordan, Libyan Arab Jamahiriya, Mauritius, Mexico, Morocco, Poland, Russian Federation, Spain.

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.

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