The Recall Desk

FDA (Devices) recall action 84382

Angiodynamics, Inc. recalled 5 products on 2019-12-25

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2019-12-25
Critical
0
Units
308

Why these products were recalled

May result in readings outside of the expected accuracy range.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··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.

    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…
    Category
    Distribution
    7 states
  • ModerateFDA (Devices)··2019-12-25

    Angiodynamics Recalls OARTRAC Prostate Balloon Kits Due to Accuracy Issues

    Angiodynamics, Inc. is recalling 160 OARTRAC Prostate Immobilization Endorectal Balloon Device Kits because they may produce readings outside the expected accuracy range.

    Product
    OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - 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…
    Category
    Distribution
    7 states
  • HighFDA (Devices)··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.

    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…
    Category
    Distribution
    7 states
  • ModerateFDA (Devices)··2019-12-25

    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.

    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…
    Category
    Distribution
    7 states
  • ModerateFDA (Devices)··2019-12-25

    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.

    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…
    Category
    Distribution
    7 states