GE Healthcare recalls MAC VU360 Electrocardiograph model 2030360-001 due to risk of assigning ECG reports to incorrect patients via display errors.
Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being assigned to the incorrect patient.
GE Healthcare is recalling its MAC VU360 electrocardiograph model 2030360-001 because it may show the wrong patient ID or visit number after scanning a barcode. This could lead to ECG reports being assigned to the wrong patient. The recall affects specific units with the model number and serial numbers listed in the notice.
The device may intermittently display incorrect patient IDs or visit numbers after scanning a patient's barcode. This error can cause ECG reports to be assigned to the wrong patient, potentially leading to misdiagnosis or inappropriate treatment.
Healthcare providers using the MAC VU360 electrocardiograph model 2030360-001 are most at risk, particularly those who rely on accurate patient identification for ECG reports.
Check for the model number 2030360-001 on the device and the serial numbers listed in the recall notice (e.g., 840682125499VU218440023SA).
Verify the model number on your MAC VU360 electrocardiograph is 2030360-001.
Check if your device's serial number matches the list of affected units provided in the recall notice.
The recalled device is the MAC VU360 model number 2030360-001.
Check if your device's serial number appears in the list of affected units provided in the recall notice.
The recall does not mention any specific fix or remedy; users are advised to check if their device is affected.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2060-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2060-2019 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.
