GE Healthcare recalls Prodigy ultrasound devices with specific model numbers due to risk of incorrect patient information being sent to PACS systems during bone density exams.
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 Prodigy ultrasound devices because they may send bone density exam reports to PACS with the wrong patient name in the DICOM header. This could lead to a patient's report being displayed under another person's name in the hospital's imaging system.
When a bone density exam report is generated using DICOM Worklist and DICOM MPPS, the patient information in the DICOM header may be incorrect. The correct patient information appears on the report image itself, but the report may show under a different patient's name in the hospital's PACS system.
Healthcare providers using GE Healthcare Prodigy ultrasound devices with the listed model numbers are affected. Patients receiving bone density exams using these devices may be at risk of receiving incorrect reports.
Check if your GE Healthcare Prodigy device has model numbers listed in the recall: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 for standard Prodigy, or LU42361, LU42397 for Prodigy Advanced.
Identify your GE Healthcare Prodigy device's model number to see if it matches the recalled list.
The recall is happening because when using DICOM Worklist with DICOM MPPS, bone density exam reports may be sent to PACS with incorrect patient information in the DICOM header.
Patients receiving bone density exams using these devices may receive reports showing under another patient's name in the hospital's imaging system, though the correct patient information is on the report image itself.
Check your device's model number against the list of recalled model numbers provided in the recall notice.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1395-2018 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1395-2018 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.
