Siemens recalls ARTISTE linear accelerator systems for cancer treatment due to potential risk of delivering radiation to the wrong body area, which could cause serious injury. Affected units have specific serial numbers.
Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
Siemens is recalling ARTISTE radiation therapy systems that could deliver radiation to the wrong body area during cancer treatment, risking serious injury. This recall affects specific models with listed serial numbers.
The system may select the wrong treatment site under specific conditions, causing radiation to be delivered to an unintended area of the body. This could lead to serious injury or damage to healthy tissue.
Patients receiving cancer radiation therapy using the affected ARTISTE systems are most at risk. Healthcare facilities that use these systems for treatment may also be impacted.
Check if your ARTISTE system has serial numbers listed: 10085, 10524, 10737, 10736, 10586, 10792, 10793, 10822, 10843, 10850, 10886, 10865, 11122. The system is used for cancer radiation therapy.
Verify your ARTISTE system's serial number against the list: 10085, 10524, 10737, 10736, 10586, 10792, 10793, 10822, 10843, 10850, 10886, 10865, 11122.
The system may select the wrong treatment site under specific conditions, which could deliver radiation to the wrong body area and cause serious injury.
Check if your ARTISTE system has serial numbers listed: 10085, 10524, 10737, 10736, 10586, 10792, 10793, 10822, 10843, 10850, 10886, 10865, 11122.
The recall does not specify a remedy, so contact Siemens directly for guidance on next steps.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0441-2022 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0441-2022 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.
