Data Foundry

Medical device recalls 2019

MICRO-PSD HDR — Class II medical device recall Z-0712-2020

Terminated recall by Angiodynamics, Inc., reported 2019-12-25, distributed nationwide. May result in readings outside of the expected accuracy range.

Recall numberZ-0712-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAngiodynamics, Inc., Queensbury, NY, United States
Recall initiated2019-11-19
Classified2019-12-19
Reported by FDA2019-12-25
Terminated2020-10-26
DistributedNationwide (US)
Quantity60 units
UPC / GTIN / UDI-DI00851546007714
Lot numbers118881, 118929, 119750
Model numbersPSD-HB5N

Product

MICRO-PSD HDR, Catalog Number: PSD-HB5N - 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-0712-2020. 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.