GE Healthcare recalls Lunar DPX NT and MD+ ultrasound devices due to risk of sending bone density reports to PACS with wrong patient names. Affected models include LU8230, LU40338, LU42357, LU42369, LU40352. No remedy specified in recall notice.
Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.
GE Healthcare is recalling specific models of their Lunar ultrasound devices because they may send bone density reports to hospital systems with the wrong patient name. This could lead to a patient's report being shown under another person's name in the hospital's digital records.
When a bone density report is sent to a hospital's PACS system using DICOM Worklist and DICOM MPPS, the patient name in the report's header may be incorrect. The actual patient name appears on the report image itself, but the system might display it under another patient's name in the hospital's digital records.
Healthcare providers using GE Healthcare Lunar DPX NT or MD+ ultrasound devices with model numbers LU8230, LU40338, LU42357, LU42369, or LU40352 are affected. Patients receiving bone density scans using these devices may be at risk of incorrect patient information appearing in hospital records.
Check if your GE Healthcare Lunar ultrasound device has model numbers LU8230, LU40338, LU42357, LU42369, or LU40352. These models are part of the DPX NT and DPX MD+ series for bone density scans.
Identify your device's model number to see if it matches the recalled models: LU8230, LU40338, LU42357, LU42369, or LU40352.
The recall is due to a risk that bone density reports may be sent to hospital systems with incorrect patient names in the DICOM header, though the correct patient name appears on the report image.
The report might appear under a different patient's name in the hospital's digital records, potentially causing confusion in patient care.
The recall notice does not specify any remedy or corrective action.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1394-2018 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1394-2018 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.
