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Terminated

DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

FDA Recall Z-2157-2013 · Posted 2013-09-04

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIXI
Date Initiated2013-08-15
Date Terminated2015-07-28
Product Quantity31

Reason for Recall

Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.

Firm Action

Important Field Safety Notices 200 01 406 030 (Changes to your system to improve the safe operation of DMLC) and 200 01 602 031 (Changes to your system to improve the safe operation of 3DLINE DMLC) letters were sent to customers on 8/15/2013 advising them of the issue and recommendations to resolve either by upgrading their system or to discontinue a clinical use of the device.

Root Cause

Device Design

Distribution Pattern

Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001163DMLC IV-ERGO3D Line USA, Inc. · 2000-10-23

Official Source

View FDA Recall →

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

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