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
Check against the official notice below — it lists the full affected range.
Elekta, Inc. is recalling 4,405 units of its medical linear accelerators across five models: the Elekta Precise Digital Accelerator, Elekta Harmony, Elekta Synergy, Elekta Infinity, and Versa HD. The devices were distributed nationwide across all U.S. states and territories, as well as internationally to multiple countries. There is a risk that the Diode D1 in the Modulator can fail destructively when removed from the machine, and the protective tube surrounding the diode may fail to contain the ejected matter.
The recall affects all serial numbers of the specified models identified by their UDI GTIN numbers and model numbers. The source record does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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, Bo Quantity: 4,405 units 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.