Agency classClass IIOur severity:High FDA (Devices)·Z-0712-2020·Announced 2019-12-25

Angiodynamics Recalls 60 Micro-PSD HDR Radiation Therapy Sensors

Angiodynamics, Inc. is recalling 60 Micro-PSD HDR sensors because they may provide readings outside the expected accuracy range.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for cancer treatment that may provide inaccurate readings. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Angiodynamics, Inc. is recalling 60 units of the MICRO-PSD HDR, Catalog Number PSD-HB5N. These pre-calibrated 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 the radiation dose received by the patient.

The recall was initiated because the devices may result in readings outside of the expected accuracy range. The affected units are identified by Lot Numbers 118881, 118929, and 119750, and UDI 00851546007714.

The products were distributed nationwide in the states of Arizona, Georgia, Massachusetts, New Jersey, New York, Ohio, and Pennsylvania. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these recalled units.

The recalled product

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…
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Radiation Therapy Sensor
Hazard: inaccurate-reading
Affected units: 60

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Lot Numbers: 118881
118929
119750 UDI:00851546007714

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Angiodynamics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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Same hazard · inaccurate reading