Siemens recalls Atellica CH 930 analyzers with software versions V1.19.2 or 1.20.0 that may display incorrect test results when scanning barcodes for certain fluids due to decimal point translation.
On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods.
Siemens is recalling Atellica CH 930 analyzers with specific software versions because scanning barcodes for some fluid types causes the system to use default values instead of correct concentrations. This could lead to inaccurate test results for sodium, potassium, and chloride measurements.
When the analyzer scans barcodes for Integrated Multisensor Technology (IMT) system fluids in regions that use commas as decimal separators (e.g., 1,02 instead of 1.02), it incorrectly translates the decimal point to a comma. This causes the system to use default values instead of the specific fluid concentrations needed for accurate test calculations.
Healthcare facilities using the Atellica CH 930 analyzer with software versions V1.19.2 or 1.20.0 are most at risk. The issue affects tests for sodium, potassium, and chloride when scanning barcodes for certain fluids.
Check if your Atellica CH 930 analyzer has software versions V1.19.2 or 1.20.0. The issue occurs when using languages that use commas for decimal points and scanning barcodes at the module console for IMT fluids.
Verify your analyzer's software version by checking the device settings or documentation.
The analyzer translates decimal points to commas when scanning barcodes for certain fluids in regions that use commas as decimal separators, causing inaccurate test results.
The system uses default values instead of specific fluid concentrations for sodium, potassium, and chloride tests, which could lead to incorrect results.
No, the recall does not require stopping use; the issue can be managed by checking software versions and ensuring proper barcode scanning practices.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0862-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0862-2020 from Siemens Healthcare. 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.
