Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to create treatment plans for any c

FDA device recall Z-2560-2011 · posted 2011-06-14 · Terminated

Recall details

Recalling firm

Computerized Medical Systems Inc

Reason for recall

Monaco: If the user selects Monte Carlo Photon as the Secondary Algorithm (to be used for final dose calculation through segments), and selects SKIP Forward button at any time during stage 2 optimization, the system may only use the pencil beam algorithm for final computation of dose even though Monte Carlo was selected. Other than specific output to the console window, there will be no other in

Action taken

Computerized Medical Systems, Inc. sent a "MONACO CUSTOMER ADVISORY" letter dated June 2008 to all affected customers. The letter describes the product, problem, and the action to be taken. The customer was instructed to use caution when using the Skip Forward button in stage 2 according to written instructions provided in the letter. This defect exists in Monaco Release 1.0.0 through 1.0.2 and will be resolved as soon as possible. Note: The issue was resolved in Monaco Release 2.0.1 and above. Questions should be directed to the manufacturer's representative telephone number at 408-830-8023.

Root cause

Software design

Status

Terminated

Product code

MUJ

Quantity affected

47

Distribution

Worldwide Distribution-- USA (nationwide) including the states of IL, MI, MO, OR, SC, TX, VA, and Puerto Rico and the countries of Canada, China, Cyprus, Estonia, France, Germany, Greece, Italy, Japan

Date initiated

2008-06-30

Date posted

2011-06-14

Date terminated

2013-04-04

Location

Maryland Heights, MO

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