OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus — Class II medical device recall Z-0710-2020
Terminated recall by Angiodynamics, Inc., reported 2019-12-25, distributed nationwide. May result in readings outside of the expected accuracy range.
| Recall number | Z-0710-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics, Inc., Queensbury, NY, United States |
| Recall initiated | 2019-11-19 |
| Classified | 2019-12-19 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2020-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| UPC / GTIN / UDI-DI | 00851546007196 |
| Lot numbers | 025-001-055-A-003, 025-001-055-A-005, 025-001-055-A-007, 025-001-055-A-008 |
| Model numbers | OTS-V2-PLUS |
Product
OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.
Reason for recall
May result in readings outside of the expected accuracy range.
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-0710-2020. 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.