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Class 2 Device Recall Oncentra Brachy |
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Date Initiated by Firm |
October 13, 2021 |
Create Date |
October 28, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0182-2022 |
Recall Event ID |
88860 |
510(K)Number |
K132816
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Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
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Product |
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 |
Code Information |
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
GTIN Numbers: 08717213052758, 08717213038660, 08717213020610, 08717213052321, 08717213052314, 08717213052307, 08717213052291, 08717213052246, 08717213052239,
08717213051881, 08717213051843, 08717213051782, 08717213051775, 08717213051294, 08717213020610, 08717213053717, 08717213053700 |
Recalling Firm/ Manufacturer |
Elekta, Inc. 400 Perimeter Center Ter NE Ste 50 Atlanta GA 30346-1227
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For Additional Information Contact |
770-670-2422
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Manufacturer Reason for Recall |
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
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FDA Determined Cause 2 |
Software design |
Action |
An Urgent Important Field Safety Notification letter (FAC-NU-0007) was issued to consignees to notify of the issue, clinical impact and recommend the following:
1) Recommended User Action in the unique scenario, which is only applicable for the Venezia" applicator: Avoid use of the combination of the two Venezia" applicator Anchor Points O1-Center and O2-Center by disabling one of them in the Applicator Library Manager.
2)Recommended User Action in the exceptional situation that may also occur for other Applicator Models: Avoid incorrect placement of the Anchor Points, especially exchanging left / right anchor point positions.
3) Recommended User Actions for both scenarios:
Until an updated version of Oncentra¿ Brachy is available, it is strongly advised:
" To use additional Anchor Points during applicator modelling. This will further reduce the chance of
mirroring the Applicator Model.
" To cross-check the source dwell position information from the Case Explorer to be in accordance
with the source dwell positions in the image views.
" Use the Triangles option for the applicator skin visualization in the 3D view, and review whether the
Applicator Model has a correct shading display.
" Perform proper Quality Assurance for all treatment plans before treatment delivery.
Consignees are required to acknowledge receipt of the notification to Elekta within 30 days. |
Quantity in Commerce |
1072 devices |
Distribution |
Distribution throughout USA
OUS distribution including:Algeria, Argentina, Australia, Austria Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = MUJ and Original Applicant = NUCLETRON B.V.
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