Oncentra Brachy users using version 4 — Class II medical device recall Z-0182-2022
Ongoing recall by Elekta, Inc., reported 2021-11-03, distributed in GA. Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid
| Recall number | Z-0182-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2021-10-13 |
| Classified | 2021-10-28 |
| Reported by FDA | 2021-11-03 |
| Distributed | GA |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BO, BR, BS, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GH, GR, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KR, MA, MX, MY, NL, NO, NZ, PE, PH, PK, PL, PT, RO, RS, SA, SE, SG, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 1,072 devices |
| UPC / GTIN / UDI-DI | 08717213020610, 08717213038660, 08717213051294, 08717213051775, 08717213051782, 08717213051843, 08717213051881, 08717213052239, 08717213052246, 08717213052291, 08717213052307, 08717213052314, 08717213052321, 08717213052758, 08717213053700, 08717213053717 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0182-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.