Elekta, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1665-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 5, 2023

Date Posted: June 7, 2023

Recall Number: Z-1665-2023

Event ID: 92270

Reason for Recall:

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

Status: Ongoing

Product Quantity: 46 units

Code Information:

Varex Part Number 95510354H-01 (Varex serial numbers 354-01H_A0010004PC to 354-01H_A0010269PC). a. Elekta Infinity: UDI-DI Number: 05060191071543, 05060191071512 (Serial Numbers: 156073, 152223, 153681); b. Versa HD: UDI-DI Number: 05060191071574, 05060191071529 (Serial Numbers: 156941, 156989, 156724, 156998); c. Elekta Synergy: UDI-DI Number: 05060191071550, 05060191071505 (Serial Number: 152483) Additional serial numbers distributed OUS: 109331, 109333, 109335, 109336, 109339, 109341, 109342, 151879, 152194, 153038, 153299, 153410, 153970, 156841, 156849, 156966, 156968, 156969, 156970, 156971, 156973, 156977, 156978, 156979, 156980, 156981, 156982, 156983, 156984, 156985, 156986, 156987, 156988, 156990, 156992, 156995, 156996, 156997.

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.

Voluntary or Mandated:

Voluntary: Firm initiated