Z-0710-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- November 19, 2019
- Termination Date
- October 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
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 of radiation dose received by the patient to the targeted area of their body.
Reason for Recall
May result in readings outside of the expected accuracy range.
Distribution Pattern
US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
Code Information
Lot Numbers: 025-001-055-A-003, 025-001-055-A-005, 025-001-055-A-007, 025-001-055-A-008 UDI: 00851546007196