Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Check against the official notice below — it lists the full affected range.
Elekta, Inc. is recalling Oncentra Brachy software version 4.0 and above with Applicator Modeling license 170283-00 due to a hazard where certain circumstances can cause a difference between the planned and delivered dose of the two ovoid channels. Approximately 1,072 devices have been distributed throughout the United States and internationally, including countries in Europe, Asia, Africa, South America, and Oceania.
The recall notice does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Reason for recall: Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels. 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) Quantity: 1072 devices Lot/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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.