| Class 2 Device Recall Monaco | |
Date Initiated by Firm | August 18, 2014 |
Date Posted | September 04, 2014 |
Recall Status1 |
Terminated 3 on September 15, 2021 |
Recall Number | Z-2581-2014 |
Recall Event ID |
68985 |
510(K)Number | K132971 |
Product Classification |
System,planning,radiation therapy treatment - Product Code MUJ
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Product | Monaco
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. |
Code Information |
Versions 3.20.00 and higher |
Recalling Firm/ Manufacturer |
Elekta, Inc. 400 Perimeter Center Ter Ne Ste 50 Atlanta GA 30346-1227
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For Additional Information Contact | Linda Wetsel 404-993-5886 |
Manufacturer 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. |
FDA Determined Cause 2 | Software design |
Action | 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. |
Quantity in Commerce | 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; and countries of: Algeria, Angola, Antigua & Barbuda, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sir Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Ukraine. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MUJ
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