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Terminated

Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.

FDA Recall Z-0014-2012 · Posted None

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2011-05-25
Date Terminated2014-01-14
Product Quantity27

Reason for Recall

It is possible to load different patients in the record and verify (R&V) system and in the multilead control software (MCS).

Firm Action

Elekta, Inc. sent an "IMPORTANT NOTICE" letter dated May 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter recommends several precautions customers should use until Elekta finds a solution. Customers will be contacted when a solution is found.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution-USA including the state of CT, FL, GA, IA, MN, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA , and WA.

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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