Angiodynamics Recalls Micro-PSD External Beam Photon Sensors
Angiodynamics, Inc. is recalling 48 Micro-PSD External Beam Photon sensors due to potential accuracy issues. The devices are used to measure radiation therapy during cancer treatment.
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 illnesses, injuries, or hospitalizations. The hazard is a potential accuracy issue in a medical device, which fits the criteria for a moderate severity score.
Plain-English summary
Angiodynamics, Inc. is recalling 48 units of the Micro-PSD External Beam Photon sensor, Catalog Number PSD-PE5N. The affected lot numbers are 106020, 106030, and 119400, with UDI 00851546007141. 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 radiation dose received by the patient.
The recall was initiated because the devices may result in readings outside of the expected accuracy range. The agency classification for this recall is Class II. The products were distributed nationwide in the states of Arizona, Georgia, Massachusetts, New Jersey, New York, Ohio, and Pennsylvania.
Healthcare facilities and users of these devices should stop using the affected sensors and contact Angiodynamics, Inc. for further instructions on the recall process.
The recalled product
- Product
- MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - 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…
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 48
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: 106020
- 106030
- 119400 UDI: 00851546007141
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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