Date Initiated by Firm | August 23, 2019 |
Create Date | August 28, 2019 |
Recall Status1 |
Terminated 3 on June 28, 2024 |
Recall Number | Z-2409-2019 |
Recall Event ID |
83604 |
510(K)Number | K190178 |
Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
|
Product | Monaco Radiation Treatment Planning System (RTP) System |
Code Information |
Software Build: 5.50.00 & 5.51.00; UDI GTIN: (01)00858164002244(10) 5.50.00, (01)00858164002268(10) 5.51.00 |
Recalling Firm/ Manufacturer |
Elekta, Inc. 400 Perimeter Center Ter NE Ste 50 Atlanta GA 30346-1227
|
For Additional Information Contact | 770-670-2422 |
Manufacturer Reason for Recall | Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup
Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions. |
FDA Determined Cause 2 | Device Design |
Action | Elekta Inc. notified customers on about 08/23/2019 via "IMPORTANT FIELD SAFETY NOTIFICATION" letter. The letter informed customers that the Monaco is displaying some incorrect shift information on the Scan and Setup Reference Report and is DICOM exporting incorrect shift information.
Instructions included that all shifts should be verified before treatment, that a software fix is planned. Customer were also instructed to post the notice in a place accessible to all users, advise personnel working with the device of the issue, and to complete and return the Acknowledgement Form provided. |
Quantity in Commerce | 49 units |
Distribution | Distribution within the US to Ohio and Indiana.
International distribution to Germany, Greece, Sweden. |
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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