Siemens recalls ARTIS Icono biplane angiography systems due to potential thermal overload in cable connectors during excessive fluoroscopy, risking imaging loss and treatment interruption.
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
Siemens is recalling ARTIS Icono biplane angiography systems because a hardware issue in the cable connectors can cause thermal overload during high use. This may lead to a burning smell, loss of imaging function, and the need to cancel treatments or switch to another system.
The cable connectors in the system generator can overheat when performing excessive fluoroscopy or acquisitions. This may cause a burning smell, temporary loss of imaging function for one plane, and require canceling treatments or switching to another system.
Healthcare facilities using the recalled ARTIS Icono biplane systems are most at risk. Patients undergoing procedures with these systems could face treatment delays or interruptions.
Check for serial numbers listed: 180550, 180517, 180518, 180546, 180547, 180560, 180534, 180556, 180537, 180545, 180533, 180566, 180536, 180563. These systems were sold with specific material and UDI-DI numbers.
If you detect a burning smell from the generator cabinet, stop using the system immediately.
Confirm your system's serial number matches the listed numbers: 180550, 180517, 180518, 180546, 180547, 180560, 180534, 180556, 180537, 180545, 180533, 180566, 180536, 180563.
The system may lose imaging functionality for one plane, causing a burning smell and requiring treatment cancellation or switching to another system.
Check for serial numbers listed: 180550, 180517, 180518, 180546, 180547, 180560, 180534, 180556, 180537, 180545, 180533, 180566, 180536, 180563.
No, but if you detect a burning smell, stop using it immediately. Otherwise, the system may continue to function safely with normal use.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2359-2023 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2359-2023 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.
