Siemens recalls specific Cios Alpha mobile X-ray systems (model 10308191) due to potential premature failure from continuous high-voltage use. Affected units may lose imaging capability.
Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a result, risk of premature failure of the Monoblock and loss of imaging X-rays.
Siemens is recalling certain Cios Alpha mobile X-ray systems because prolonged use at high tube voltages (125 kV for 30+ minutes) can cause premature failure of the radiation components. This may lead to loss of imaging capability without warning.
Continuous operation at high tube voltages (125 kV) for extended periods—like 30 minutes or more—increases wear on the radiation-emitting parts. This can cause the Monoblock component to fail prematurely, resulting in loss of X-ray imaging capability.
Healthcare facilities using the specific model number 10308191 mobile X-ray systems are most at risk. Pediatric patients receiving imaging procedures with these systems could be affected.
Check for the model number 10308191 on the mobile X-ray system. Affected units have serial numbers listed in the recall notice (e.g., 11294, 11202, 12006, etc.).
Verify the model number on your mobile X-ray system. Affected units have model number 10308191.
Prolonged use at high tube voltages (125 kV) for 30+ minutes can cause premature failure of the radiation-emitting components.
The system may lose imaging capability, but this does not pose a risk of injury to patients or users.
Check the model number on your mobile X-ray system. Affected units have model number 10308191 and specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1298-2019 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1298-2019 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.
