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Terminated

Monaco Product Usage: Planning of radiation therapy

FDA Recall Z-2007-2012 · Posted 2012-07-12

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2012-06-21
Date Terminated2014-04-01
Product Quantity38

Reason for Recall

Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.

Firm Action

Elekta sent an Important Safety Notice to affected customers. The notice identified the affected product, problem, clinical impact and actions to be taken. The notice inform customers of how the issue will be resolved and instructions to follow when it is available.

Root Cause

Software design

Distribution Pattern

US Nationwide Distribution - including the states of: CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110730MONACO RTP SYSTEMComputerized Medical Systems, Inc. · 2011-06-24

Official Source

View FDA Recall →

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

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