Angiodynamics Recalls MICRO-PSD Electron Sensors Due to Accuracy Concerns
Angiodynamics, Inc. is recalling 36 units of MICRO-PSD Electron 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Angiodynamics, Inc. is recalling 36 units of the MICRO-PSD Electron, Catalog Number PSD-EE5N. 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 the measurement and validation of 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 Number 119788 and UDI 00851546007615.
The products were distributed nationwide in the states of Arizona, Georgia, Massachusetts, New Jersey, New York, Ohio, and Pennsylvania. Healthcare providers and facilities should stop using the affected sensors and contact the recalling firm for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 36
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 (1)
- Lot Numbers: 119788 UDI: 00851546007615
Distribution
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.
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