FDA Device recall Z-0182-2022
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
- FDA Device
- Class II
- ongoing
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class II recall of Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 by Elekta, citing under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0182-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-13 |
| Published | 2021-11-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Elekta |
| Distribution | GA |
Product
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Reason
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Identifiers
| code_info | Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 GTIN Numbers: 08717213052…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0182-2022%22
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