CLASS II ONGOING Device recall · Reported 3 Nov 2021 · FDA Enforcement Report

Oncentra Brachy users using recalled by Elekta

Elekta is recalling Oncentra Brachy users using, distributed in Georgia. The recall was initiated on 13 Oct 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesOncentra 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

Quantity recalled1072 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0182-2022
FDA event ID: 88860
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Ongoing
Recall initiated: 13 Oct 2021
FDA classified: 28 Oct 2021
Reported: 3 Nov 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Oct 2021	Recall initiated by company
28 Oct 2021	Classified by FDA	+15 days
3 Nov 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.

Product as listed by the FDA

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

Where it was distributed

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

Georgia

Questions about this recall

Is Oncentra Brachy users using recalled?

Yes. Elekta recalled Oncentra Brachy users using on 13 Oct 2021. The recall is Class II and its status is Ongoing. Recall number Z-0182-2022.

Why was it recalled?

Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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