Monaco RTP System Radiation treatment planning

FDA device recall Z-2276-2013 · posted 2013-09-25 · Terminated

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.

Action taken

Monaco 3.3 upgrades have been temporarily halted and Important Safety Notice (LINMON0007) has been issued to effected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that couch files are checked for releases 3.20.00 and 3.30.00 to verify that the correct relative electron density values are being used in the dose calculation. If customers have edited the sample couch files, and previously upgraded to Monaco 3.20.00 or 3.30.00, their couch files have already been overwritten. Open the couch files, make the necessary updates to the couch parameters, and use the "Save As Treatment Couch" option to save the modified sample couch files to a new, unique name. Please note that the couch files can also be edited in Focal and then the patients opened in Monaco. Comparable Focal releases would be Focal4.64.00(Monaco 3.10.00), Focal4.70.00(Monaco 3.20.00) and Focal4.80.00 (Monaco 3.30.00). For questions regarding this recall call 404-993-5886.

Root cause

Device Design

Status

Terminated

Product code

MUJ

Quantity affected

45

Distribution

Nationwide Distribution including AK, CA, CO, CT, FL, IL, IN, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, WA and Puerto Rico.

Date initiated

2013-07-02

Date posted

2013-09-25

Date terminated

2014-05-08

Location

Atlanta, GA

Related 510(k) clearances