Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation the

FDA device recall Z-2581-2014 · posted 2014-09-04 · Terminated

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.

Action taken

The firm, Elekta, issued an "URGENT IMPORTANT FIELD SAFETY NOTICE (IFSN 382-01-MON-001)" to all affected customers on August 18, 2014. The notice describes the product, problems and actions taken. Confirmation of receipt is to be completed by October 31, 2014. The problem will be resolved in patches to the following releases - Monaco 3.30 and Monaco 5.00. Development is underway with a release date of September 2014 with confirmation of installation of the patch no later than 6 months from release of the patch. An updated notice from the manufacturer is also being sent to affected customers (FCO: 382-01-MON-001 VID:2.0). If you have any queries about this Notice, please contact your local Elekta office or call 770-300-9725 or email: Elekta_Global_PMS@elekta.com.

Root cause

Software design

Status

Terminated

Product code

MUJ

Quantity affected

928 units

Distribution

Worldwide distribution: US (nationwide) including states of: AL, AK, AZ, CA, CO, CT, FL, IL, IN, MD, MA, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, Puerto Rico; an

Date initiated

2014-08-18

Date posted

2014-09-04

Date terminated

2021-09-15

Location

Atlanta, GA

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