GE Medical Systems recalls two ECG analysis systems due to software that may link clinical data to wrong patients, risking incorrect medical decisions. Affected units have specific model numbers and software versions.
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.
GE Medical Systems is recalling two ECG analysis systems because software in the latest version could link patient data to the wrong person. This might lead to incorrect medical decisions if the software error is not fixed.
The software version 3.00 has a bug that might connect clinical information to the wrong patient. This could cause healthcare providers to make incorrect medical decisions based on the wrong patient data.
Healthcare providers using the MAC 5 A4 or MAC 5 A5 ECG systems with software version 3.00 are most at risk. Patients using these systems for medical monitoring could be affected if the software error occurs.
Check for the model numbers 855001-001 (MAC 5 A4) or 8855002-001 (MAC 5 A5) with software version 3.00. The units have specific UDI-DI numbers listed in the recall notice.
Verify the software version on your ECG system; if it is 3.00, it is affected.
The software error could lead to incorrect patient data being linked, which might impact clinical decisions, but it does not cause immediate harm.
Check for model numbers 855001-001 (MAC 5 A4) or 8855002-001 (MAC 5 A5) with software version 3.00.
The recall does not specify a remedy, so you should check the software version and contact GE Medical Systems for further instructions.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2306-2026 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2306-2026 from GE Medical Systems. 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.
