GE Healthcare recalls Centricity Cardiology CA1000 software versions 1.0 to 1.0 SP and 2.0 to 2.0 SP14H due to potential inaccurate distance and area measurements when using magnified or scaled-down images.
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
GE Healthcare is recalling the Centricity Cardiology CA1000 medical imaging software versions 1.0 through 1.0 SP and 2.0 through 2.0 SP14H. Inaccurate measurements can occur when using magnified or scaled-down images, which may affect medical diagnoses.
The software may display inaccurate distance and area measurements when images are magnified or scaled down from their original resolution. This could lead to incorrect medical assessments if the measurements are critical for diagnosis.
Healthcare providers using the Centricity Cardiology CA1000 software versions 1.0 through 1.0 SP and 2.0 through 2.0 SP14H are affected. Medical professionals who rely on precise measurements for cardiology imaging are at the highest risk.
Check if your software version is 1.0 through 1.0 SP or 2.0 through 2.0 SP14H. The product includes specific GTIN/DI codes for identification.
Review your software version to determine if it falls within the recalled range (1.0 through 1.0 SP or 2.0 through 2.0 SP14H).
Software versions 1.0 through 1.0 SP and 2.0 through 2.0 SP14H are affected.
Inaccurate distance and area measurements when using magnified or scaled-down images could lead to incorrect medical diagnoses.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1232-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1232-2022 from GE 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.