Home / Recalls / Elekta, Inc. / Z-0182-2022

Z-0182-2022 Class II Ongoing

Recalled by Elekta, Inc. — Atlanta, GA

Recall Details

Product Type
Devices
Report Date
November 3, 2021
Initiation Date
October 13, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1072 devices

Product Description

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

Reason for Recall

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

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

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

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