Recalls / —

—#121168

Product

Monaco RTP System Radiation Therapy Treatment Planning 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

All versions of Monaco

Why it was recalled

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

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm

Elekta, Inc.

Address

400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

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.

Timeline

Recall initiated

2013-05-22

Posted by FDA

2013-09-25

Terminated

2013-12-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #121168. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.