Elekta, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Elekta, Inc. is recalling Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelera due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026