Siemens recalls specific models of Cios Alpha and Spin mobile X-ray systems due to a hardware error that can cause permanent loss of imaging functionality if hot plugging is used on older generator revisions.
Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging functionality.
Siemens is recalling certain models of Cios Alpha and Cios Spin mobile X-ray systems because a hardware error in the generator's main control unit could cause permanent loss of imaging functionality if hot plugging is used on older revisions. This affects medical imaging equipment used in clinical settings.
The hardware error in the generator's main control unit (D80) can cause permanent loss of imaging functionality when hot plugging is used on older revisions of the generator below revision 04. This means the X-ray system may stop working entirely if the error is triggered during normal use.
Medical facilities that own or use the recalled Siemens Cios Alpha and Cios Spin mobile X-ray systems are most at risk. The recall covers specific model numbers used in clinical applications.
Check the model numbers listed in the recall notice: Cios Alpha (VA20) model 10308191, Cios Alpha (VA30) model 11105200, and Cios Spin (VA30) model 10308194. The affected systems also include specific serial numbers starting with 10xxx, 11xxx, 12xxx, 13xxx, 4xxxx, and 5xxxx as detailed in the recall list.
Review the model numbers listed in the recall notice to confirm if your system is affected.
The recall is due to a hardware error in the generator's main control unit that can cause permanent loss of imaging functionality when hot plugging is used on older revisions of the generator below revision 04.
The affected models include Cios Alpha (VA20) model 10308191, Cios Alpha (VA30) model 11105200, Cios Spin (VA30) model 10308194, and specific serial numbers starting with 10xxx, 11xxx, 12xxx, 13xxx, 4xxxx, and 5xxxx as listed in the recall notice.
The recall notice does not specify a remedy, so you should contact Siemens Medical Solutions USA, Inc 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-2848-2020 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2848-2020 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.