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Terminated

MLCi/MCLi2. Radiation therapy.

FDA Recall Z-1651-2012 · Posted 2012-05-23

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2012-04-19
Date Terminated2014-10-06
Product Quantity386

Reason for Recall

The Y2 diaphragm block was found loose.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution including Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082122MLCI2Elekta , Ltd. · 2008-08-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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