The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0710-2020·Announced 2019-12-25

Angiodynamics Recalls OARtrac PLUS Clinical Detector Units Due to Accuracy Issues

Angiodynamics, Inc. is recalling four OARtrac PLUS Clinical Detector Units because they may produce 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 radiation therapy dosimetry where inaccuracy poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Angiodynamics, Inc. is recalling four units of the OARtrac PLUS CLINICAL DETECTOR UNIT (Catalog Number: OTS-V2-Plus). These 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 the radiation dose received by the patient to the targeted area of their body.

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 025-001-055-A-003, 025-001-055-A-005, 025-001-055-A-007, and 025-001-055-A-008, and UDI 00851546007196.

The units were distributed nationwide in the states of Arizona, Georgia, Massachusetts, New Jersey, New York, Ohio, and Pennsylvania. Healthcare facilities and users should stop using the affected units and contact Angiodynamics, Inc. for further instructions.

The recalled product

Product
OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - 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…
Manufacturer
Angiodynamics, Inc.
Category
Medical Device — Radiation Therapy Detector
Hazard
Affected units
4

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 (4)

  • Lot Numbers: 025-001-055-A-003
  • 025-001-055-A-005
  • 025-001-055-A-007
  • 025-001-055-A-008 UDI: 00851546007196

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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