Z-0711-2020Class II

MICRO-PSD Electron, Catalog Number: PSD-EE5N -

Name: Z-0711-2020 MICRO-PSD Electron, Catalog Number: PSD-EE5N -
Creator: Angiodynamics, Inc.
Published: 2019-11-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2019-11-19 / Terminated

FDA source

Angiodynamics, Inc. began a recall of MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and... on 2019-11-19. FDA classified it as Class II and gives the reason as "May result in readings outside of the expected accuracy range". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0711-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-19
Posted: 2019-12-19
Terminated: 2020-10-26
Recalling firm: Boston Scientific Corporation
Product: MICRO-PSD Electron, Catalog Number: PSD-EE5N - 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.
Product code: NZT Dosimeter, Ionizing Radiation, Implanted
Reason for recall: May result in readings outside of the expected accuracy range.
FDA root cause: Under Investigation by firm
Action: AngioDynamics issued Urgent Medical Device Correction Letter on November 19, 2019, via Federal Express. The letter states reason for recall , health risk and action to take: Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). Segregate and return all affected devices to AngioDynamics, Inc. Consignees are directed to complete and return the Reply Verification Tracking Form, provided in the recall notification. cCall AngioDynamics Customer Service at 1-800- 772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain an RMA for your returned product.
Quantity in commerce: 36 units
Distribution: US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
Product codes and lots: Lot Numbers: 119788 UDI: 00851546007615

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0711-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0709-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-19
Z-0710-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-19
Z-0711-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-19
Z-0712-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-19
Z-0713-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-19

Product code NZT

K182395Class IIOARtrac SystemRadialdyne, LLC / cleared 2019-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)