Siemens recalls ARTIS pheno model 10849000 interventional fluoroscopy systems that may show zero x-ray dose during patient exams, but actual radiation is still applied.
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
Siemens is recalling its ARTIS pheno model 10849000 interventional fluoroscopy systems because they occasionally display a zero x-ray dose reading during patient exams, while still delivering actual radiation. This means patients could receive unintended radiation exposure even when the system shows no dose.
The system may show a zero x-ray dose reading during patient exams, but actual radiation is still being delivered. This happens only during fluoroscopy or single-frame acquisitions. The radiation exposure is not directly harmful to patients but could lead to unintended cumulative exposure over time.
Patients undergoing interventional fluoroscopy procedures using this specific Siemens ARTIS pheno model 10849000 system are affected. Medical staff using the equipment may also be at risk if they don't recognize the display issue.
Check for the model number 10849000 on the ARTIS pheno interventional fluoroscopy system. The system has a unique device identifier (UDI) of 4056869046877. This recall applies to systems sold in the U.S. by Siemens Medical Solutions USA, Inc.
Look for the model number 10849000 on the system and verify the unique device identifier (UDI) 4056869046877.
The recall indicates the system may show zero x-ray dose during exams but still delivers radiation. While not immediately harmful, it could lead to unintended cumulative radiation exposure over time.
Check for the model number 10849000 and unique device identifier (UDI) 4056869046877 on the system.
The recall does not specify a remedy, so no action is required beyond checking if your system matches the model and UDI.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2205-2026 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2205-2026 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
