Angiodynamics, Inc. recalls OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE K
Recalled 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 measurement and validation of radiation dose received by the patient to the targeted area of their body.
Hazard / Issue
May result in readings outside of the expected accuracy range.
Issued by
FDA
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