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Terminated

Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

FDA Recall Z-0885-2013 · Posted 2013-02-26

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIXI
Date Initiated2013-01-18
Date Terminated2014-05-08
Product Quantity1

Reason for Recall

If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.

Firm Action

Elekta sent an Important Field Safety Notice Field Safety Notice FCO Ref: 20001407029 "Important information for the safe and satisfactory operation of Apex" to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to obey all the applicable instructions, warning, and cautions in the user documentation for each piece of equipment. For questions regarding this recall call 770-300-9725.

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution including TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111676APEXElekta Limited · 2011-09-30

Official Source

View FDA Recall →

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

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