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Terminated

Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.

FDA Recall Z-2277-2013 · Posted 2013-09-25

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2013-05-22
Date Terminated2013-12-23
Product Quantity72

Reason for Recall

Patient needs to be positioned as indicated by the treatment plan.

Firm Action

Computerized Medical Systems issued an Important Safety Notice dated May 22, 2013 to all affected customers. This letter idenitfies the problems the products and the actions needed to be takem by the custom.

Root Cause

Labeling design

Distribution Pattern

Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.

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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