Siemens recalls Biograph mCT and Biograph mCT Flow systems due to potential laser cover windows falling off. Affected models include S(64)-3R, S(40)-4R, and others with specific material numbers and serial numbers.
Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biograph mCT and Biograph mCT Flow systems.
Siemens is recalling several models of Biograph mCT and Biograph mCT Flow systems because some laser cover windows may fall off. This could cause the scanner to malfunction or pose a safety risk during medical imaging procedures.
The laser cover windows in a limited population of these systems may detach. If this happens, it could cause the scanner to malfunction or pose a safety risk during medical imaging procedures, potentially affecting patient safety.
Healthcare professionals who use these medical imaging systems are most at risk. The recall affects specific models of Siemens Biograph mCT and Biograph mCT Flow systems used in hospitals and medical facilities.
Check for the specific model names and material numbers listed in the recall notice. Affected units include Biograph mCT S(64)-3R (Material Number 10248669), Biograph mCT S(40)-4R (Material Number 10248671), and other models with the listed serial numbers.
Identify your model and material number by checking the product label or documentation. Affected models include Biograph mCT S(64)-3R (Material Number 10248669) and others with specific serial numbers listed in the recall.
Siemens became aware through a supplier that some laser cover windows may fall off a limited population of these systems.
The recall includes specific models like Biograph mCT S(64)-3R (Material Number 10248669), Biograph mCT S(40)-4R (Material Number 10248671), and others with the listed serial numbers.
No, the recall does not require immediate discontinuation. Healthcare professionals should check the product details to confirm if their system is affected and follow the provided steps.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2248-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2248-2018 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.
