Siemens recalls Symbia Intevo 6 SPECT/CT systems with software version VB20A that may have calibration errors affecting radionuclide imaging. Affected units require software update to prevent inaccurate measurements.
The Broad Quantification option of the Symbia product software version VB20A may not allow modification of two data input values. The failure occurs when the system with the Broad Quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered.
Siemens is recalling Symbia Intevo 6 SPECT/CT systems with software version VB20A that may not properly handle certain calibration settings. This could lead to inaccurate medical imaging results if the system is used with specific phantom volumes or residual dose inputs.
The software may not allow modification of two critical data input values when calibrated with phantoms that don't have a 6500ml volume or when residual dose needs to be entered. This could cause inaccurate measurements in medical imaging studies.
Healthcare facilities using the Symbia Intevo 6 system with software version VB20A are most at risk. The recall affects specific serial numbers (2141, 2144) that were sold in the U.S. for medical imaging.
Check if your Symbia Intevo 6 system has software version VB20A and serial numbers 2141 or 2144. These units were sold in the U.S. for medical imaging purposes.
Verify your system's software version is VB20A and check the serial number against the affected numbers (2141, 2144).
The software may not allow modification of two data input values when calibrated with specific phantoms or residual dose inputs, potentially causing inaccurate medical imaging results.
This could lead to inaccurate measurements in radionuclide imaging studies, which might impact diagnosis and treatment planning for conditions like cancer and cardiovascular disease.
The recall record does not specify a remedy or action steps for affected units. You should contact Siemens directly for further guidance.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0094-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0094-2018 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.
