Siemens recalls Cios Alpha mobile X-ray systems with software version VA30-mobile due to potential premature failure of radiation components from continuous high-output use. Affected units may lose imaging capability.
Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists
Siemens is recalling mobile X-ray systems with software version VA30-mobile because continuous high-output use can cause radiation-emitting components to wear out faster, potentially leading to system failure and loss of imaging capability. This affects medical facilities using the equipment for procedures like interventional fluoroscopy and cardiac imaging.
Continuous operation at high tube outputs causes radiation-emitting components to wear out faster than expected. This may lead to premature failure of the Monoblock component and loss of imaging X-rays, but does not pose an immediate safety risk to patients or staff.
Medical facilities using Siemens Cios Alpha mobile X-ray systems with software version VA30-mobile for procedures like interventional fluoroscopy or cardiac imaging are most affected. Pediatric patients using these systems are also at risk due to the equipment's clinical applications.
Check if your Siemens Cios Alpha mobile X-ray system has software version VA30-mobile. The product was sold with material number 11105200 for clinical procedures including interventional fluoroscopy and cardiac imaging.
Verify your Siemens Cios Alpha system's software version by checking the device settings or documentation.
Continuous high-output use of the Cios Alpha system with software version VA30-mobile may cause radiation-emitting components to wear out faster, potentially leading to premature failure of the Monoblock and loss of imaging capability.
The recall does not specify a remedy, so no action is required. Check your software version to confirm if you are affected.
The recall indicates potential loss of imaging capability but does not mention patient safety risks. The hazard is related to equipment failure, not direct harm to patients.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1295-2019 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1295-2019 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.
