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8 reported ongoing
9 records in this archive. Latest source date Feb 3, 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.
It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. ...
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.
Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
Class IIReported ongoing
Distribution: IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden
Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG...
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the state of Virginia and the country of India.
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore...
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is...
Class IIReported ongoing
Distribution: IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, Netherlands,
Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented e...
Class IIReported terminated
Distribution: IN USA: VA, OK, NJ, TN OUS: Czech Republic.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 9 records, including 8 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.