Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Reported: November 3, 2021 Initiated: October 13, 2021 #Z-0182-2022
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.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 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
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00. Recalled by Elekta, Inc.. Units affected: 1072 devices.
Why was this product recalled? ▼
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 3, 2021. Severity: Moderate. Recall number: Z-0182-2022.
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