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.
Reported: December 25, 2019 Initiated: November 19, 2019 #Z-0709-2020
Product Description
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.
Reason for Recall
May result in readings outside of the expected accuracy range.
Details
- Recalling Firm
- Angiodynamics, Inc.
- Units Affected
- 160 units
- Distribution
- US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
- Location
- Queensbury, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Angiodynamics, Inc.. Units affected: 160 units.
Why was this product recalled? ▼
May result in readings outside of the expected accuracy range.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2019. Severity: Moderate. Recall number: Z-0709-2020.
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