openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 5
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.
May result in readings outside of the expected accuracy range.
Code information
Lot Numbers: 114290, 114935 UDI 00851546007066
Distribution pattern
US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
device · product 2 of 5
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.
May result in readings outside of the expected accuracy range.
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
Distribution pattern
US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
device · product 3 of 5
MICRO-PSD Electron, Catalog Number: PSD-EE5N - 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.
May result in readings outside of the expected accuracy range.
Code information
Lot Numbers: 119788 UDI: 00851546007615
Distribution pattern
US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
device · product 4 of 5
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.
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.
device · product 5 of 5
MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - 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.
