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48 reported ongoing
50 records in this archive. Latest source date May 20, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixati...
Class IIReported ongoing
Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixati...
Class IIReported ongoing
Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixati...
Class IIReported ongoing
Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixati...
Class IIReported ongoing
Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixati...
Class IIReported ongoing
Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixati...
Class IIReported ongoing
Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixati...
Class IIReported ongoing
Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixati...
Class IIReported ongoing
Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixati...
Class IIReported ongoing
Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, Fran...
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, Fran...
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, Fran...
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, Fran...
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, Fran...
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, Fran...
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, Fran...
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, Fran...
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, Fran...
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 50 records, including 48 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.