FDA Enforcement
Class II
Terminated
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 by the patient to the targeted area of their body.
Recall: Z-0712-2020
·
Reported December 25, 2019
Enforcement
- Recall Number
- Z-0712-2020
- Event ID
- 84382
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Angiodynamics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 25, 2019
- Initiation Date
- November 19, 2019
- Classification Date
- December 19, 2019
- Termination Date
- October 26, 2020
- Address
- 603 Queensbury Ave, Queensbury, NY, 12804-7619, United States
Description
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 by the patient to the targeted area of their body.
Reason
May result in readings outside of the expected accuracy range.
Code Info
Lot Numbers: 118881, 118929, 119750 UDI:00851546007714
Distribution
US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
Quantity
60 units