GE Healthcare Lunar: a) DPX Duo — Class II medical device recall Z-1393-2018
Terminated recall by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, reported 2018-04-25, distributed nationwide. Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam ma
| Recall number | Z-1393-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, Madison, WI, United States |
| Recall initiated | 2018-03-16 |
| Classified | 2018-04-17 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2020-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, DE, EG, ES, FI, FR, GB, GR, HK, IE, IL, IN, IT, JP, KR, LB, MA, MT, MX, MY, NO, PL, PT, RO, RU, SA, TN, TR, TW, VE |
| Quantity | 26 units |
| Model numbers | LU41692, LU41693 |
Product
GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1393-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.