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OARtrac

RADIADYNE, L.L.C. · Model OT-CDU2P · UDI-DI 00851546007196

NZT
1
510(k) clearances
0
Adverse events
5
Recalls
0
Facilities

Description

OARtrac Plus Clinical Detector Unit (CDU)

Recalls

DateFirmReason
2019-11-19Angiodynamics, Inc.May result in readings outside of the expected accuracy range.
2019-11-19Angiodynamics, Inc.May result in readings outside of the expected accuracy range.
2019-11-19Angiodynamics, Inc.May result in readings outside of the expected accuracy range.
2019-11-19Angiodynamics, Inc.May result in readings outside of the expected accuracy range.
2019-11-19Angiodynamics, Inc.May result in readings outside of the expected accuracy range.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.