Device 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 by the patient to the targeted area of their body.
Z-0712-2020
Product summary
- Event
- Event 84382
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-0712-2020
Official wording
Reason: May result in readings outside of the expected accuracy range.
Code information: Lot Numbers: 118881, 118929, 119750 UDI:00851546007714
Distribution pattern: US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
Derived failure modes
-
Unknown
May result in readings outside of the expected accuracy range.