GE Healthcare recalls Lunar DPX Duo (LU41693) and DPX Bravo (LU41692) ultrasound devices due to potential incorrect patient information in PACS reports, which could lead to misidentification 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 two ultrasound devices that provide bone density measurements. The devices may send reports with the wrong patient name to hospital imaging systems, risking misidentification of patients during bone density exams.
When DICOM Worklist and DICOM MPPS are used together, bone density reports can be sent to hospital imaging systems with incorrect patient names in the report headers. 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 imaging system.
Patients receiving bone density scans using these specific GE Healthcare Lunar ultrasound devices are affected. Healthcare providers using the devices for bone density exams may be at higher risk.
Check for the model numbers LU41693 (DPX Duo) or LU41692 (DPX Bravo) on the device. These devices provide bone density measurements at the lumbar spine and hip regions.
Identify the model number on the device to confirm if it is LU41693 (DPX Duo) or LU41692 (DPX Bravo).
The recall is due to a potential risk of sending bone density reports with incorrect patient names to hospital imaging systems, which could lead to misidentification.
Check the model number on the device to see if it is LU41693 (DPX Duo) or LU41692 (DPX Bravo). If it is, contact GE Healthcare for further instructions.
The recall does not indicate a risk of serious injury; the hazard involves potential misidentification of patients in imaging systems, not physical harm.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1393-2018 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1393-2018 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.
