Z-0115-2022Class II

Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and...

Name: Z-0115-2022 Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and...
Creator: Elekta Solutions Ab
Published: 2021-09-28
License: https://open.fda.gov/license/

Elekta Solutions AB / initiated 2021-09-28 / Terminated / root cause: manufacturing process

FDA source

ELEKTA SOLUTIONS AB began a recall of Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093 on 2021-09-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0115-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-28
Posted: 2021-10-14
Terminated: 2024-06-14
Recalling firm: Elekta Solutions AB
Product: Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued an Urgent Important Field Safety Notification dated September 2021 via email on 9/28/2021. The Subject of the letter was addressed for the service user regarding precautions to be taken when handling diode D1. The notification described the details of the failure and that Elekta is currently working on a solution to eliminate this failure mode. The notice was to be placed in an area accessible to all users until the correction is made. Appropriate personnel who work with this product are to be advised on the content of the letter. Corrective actions were provided regarding removing the modulator covers and the Personal Protective Equipment that must be worn by the engineer, including a safety visor, protective jacket, and gloves. Instructions for removing the RDO diode (D1) were provided. An Acknowledgment Form was included for completion and return to Elekta no later than 30 days for acknowledgement that the service user has read and understands the notification and accepts the implementation of any given recommendation.
Quantity in commerce: 2 in the U.S.
Distribution: Distribution was to ND and NC. There was no military/government distribution.
Product codes and lots: Elekta Harmony Pro, Serial #441009, UDI (01) 05060191071604; Elekta Infinity, Serial #156645, UDI (01) 05060191071543; and Elekta Versa HD, Serial #156646, #156477, and #156648, UDI (01) 05060191071574

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0115-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0115-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-14

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)