Recall Z-0182-2022 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
| Date | Oct 13, 2021 |
| Status | Open, Classified |
| Reason | Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels. |
| Root cause | Software design |
| Action | An Urgent Important Field Safety Notification letter (FAC-NU-0007) was issued to consignees to notify of the issue, clinical impact and recommend the following: 1) Recommended User Action in the unique scenario, which is only applicable for the Venezia" applicator: Avoid use of the combination of the two Venezia" applicator Anchor Points O1-Center and O2-Center by disabling one of them in the Applicator Library Manager. 2)Recommended User Action in the exceptional situation that may also occur for other Applicator Models: Avoid incorrect placement of the Anchor Points, especially exchanging |
| Quantity | 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, German |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132816 | ONCENTRA BRACHY Nucletron B.V., Jun 13, 2014 |