Elekta, Inc. Recall 88860
Description: Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Elekta, Inc. Recall 88860 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0182-2022 |
| Event ID | 88860 |
| Event Description | Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 |
| Product Type | 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 |
| Quantity | 1072 devices |
| Recall Reason | Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels. |
| Device Classification | 20211103 |
| Device Code Info | 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 |
| Center Classification Date | 20211028 |
| Recall Initiation Date | 20211013 |
| Recalling Firm | Elekta, Inc. |
| Initial Notification | Letter |
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