Z-1651-2012

MLCi/MCLi2. Radiation therapy

Name: Z-1651-2012 MLCi/MCLi2. Radiation therapy
Creator: Elekta, Inc.
Published: 2012-04-19
License: https://open.fda.gov/license/

Elekta Limited / initiated 2012-04-19 / Terminated / root cause: manufacturing process

FDA source

Elekta, Inc. began a recall of MLCi/MCLi2. Radiation therapy on 2012-04-19. The reason FDA records is "The Y2 diaphragm block was found loose". 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-1651-2012
Status: Terminated
Initiated: 2012-04-19
Posted: 2012-05-23
Terminated: 2014-10-06
Recalling firm: Elekta Limited
Product: MLCi/MCLi2. Radiation therapy.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The Y2 diaphragm block was found loose.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated April 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to carry out the recommended weekly physics check of the X-ray and light field size calibration. If an error is found, customers are instructed to contact their local Elekta service engineer.
Quantity in commerce: 386
Distribution: Nationwide Distribution including Puerto Rico.
Product codes and lots: MRT 2424/MRT 14401

Product code IYE

K082122Class IIMlci2Elekta , Ltd. / cleared 2008-08-29

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)