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Recall Observatory FDA recall evidence

Device product

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

Z-0182-2022

October 13, 2021

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 88860
Status
Ongoing
Classification
Class II
Quantity
1072 devices
Official record key
device-enforcement:Z-0182-2022

Official wording

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

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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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