Z-1665-2023Class II

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

Name: Z-1665-2023 Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c...
Creator: Elekta, Inc.
Published: 2023-05-05
License: https://open.fda.gov/license/

Elekta Limited / initiated 2023-05-05 / Open, Classified

FDA source

Elekta, Inc. began a recall of Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy on 2023-05-05. FDA classified it as Class II and gives the reason as "A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1665-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-05
Posted: 2023-05-30
Recalling firm: Elekta Limited
Product: Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
FDA root cause: Under Investigation by 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.
Quantity in commerce: 46 units
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1665-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1665-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-30

Product code IYE

K210500Class IIElekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited / cleared 2021-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)