Siemens recalls ARTIS angiography systems that may incorrectly report high radiation doses due to rare sensor-software communication failure. Affected systems require immediate attention to prevent potential overexposure risks.
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Siemens is recalling its ARTIS angiography systems because rare sensor-software communication failures can cause the system to incorrectly report high radiation doses. This could lead to unnecessary radiation exposure during medical procedures.
The system's sensor and software occasionally fail to communicate, causing it to report a high radiation dose when the actual dose is lower. This could result in unnecessary radiation exposure during medical imaging procedures.
Medical facilities using Siemens ARTIS angiography systems for procedures like cardiac or neuro-angiography are affected. Patients undergoing these procedures with the recalled systems may be at risk of unnecessary radiation exposure.
The ARTIS angiography systems are used for procedures such as cardiac angiography and neuro-angiography. These systems were sold starting from the time of their introduction in the medical market.
Verify if your system has the reported sensor-software communication issue by reviewing the system logs or contacting Siemens support.
The recall applies to all Siemens ARTIS angiography systems used for procedures like cardiac or neuro-angiography. Check your system's model and purchase date for more details.
The recall record does not specify a remedy, so no immediate fix is provided. Contact Siemens for further assistance.
The hazard is described as a rare communication failure that may incorrectly report high radiation doses, but no serious injury mechanism is mentioned.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2019-2025 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2019-2025 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.
