—#121167

Product

Monaco RTP System Radiation treatment planning

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K110730
Affected lot / code info: Versions 3.10.00 and later

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-07-02
Posted by FDA: 2013-09-25
Terminated: 2014-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121167. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.