Z-0182-2022Class II

Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00

Name: Z-0182-2022 Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Creator: Elekta, Inc.
Published: 2021-10-13
License: https://open.fda.gov/license/

Elekta Limited / initiated 2021-10-13 / Open, Classified / root cause: software

FDA source

Elekta, Inc. began a recall of Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 on 2021-10-13. FDA classified it as Class II and gives the reason as "Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0182-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-13
Posted: 2021-10-28
Recalling firm: Elekta Limited
Product: Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Root cause tag: software
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0182-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0182-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-03	2021-10-28

Product code MUJ

K132816Class IIOncentra BrachyNucletron B.V. / cleared 2014-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)