GE Healthcare recalls cardiac assessment software versions v6.6x, v6.7x, v7.0 due to risk of patient test reports appearing in incorrect records. Affected users should contact GE for details.
If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an Electronic Medical Record (EMR) or a similar system.
GE Healthcare is recalling specific versions of their cardiac assessment software because patient test reports can appear in the wrong medical records. This could lead to incorrect medical decisions if not fixed.
The software may display a patient's test report in another patient's medical record if a specific sequence of events happens. This could cause confusion in medical decisions but does not involve physical harm to users.
Healthcare providers using the Case Cardiac Assessment System or CardioSoft Diagnostic System software versions v6.6x, v6.7x, and v7.0 are most at risk. Patients are not directly affected as the issue is with the software records.
Check if you have the Case Cardiac Assessment System or CardioSoft Diagnostic System software versions v6.6x, v6.7x, or v7.0. The software is used for cardiac stress testing and ECGs in healthcare settings.
Reach out to GE Healthcare for specific guidance on the affected software versions and next steps.
No, the recall involves software records, not physical patient harm. Patients are not directly affected.
Software versions v6.6x, v6.7x, and v7.0 of the Case Cardiac Assessment System and CardioSoft Diagnostic System.
Check your software version in the Case Cardiac Assessment System or CardioSoft Diagnostic System for cardiac stress testing and ECGs.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1927-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1927-2021 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.