# FDA recall Z-1395-2018

> **GE Medical Systems Ultrasound & Primary Care Diagnostics, LL** · Class II · device recall initiated 2018-03-16.

## Product

GE Healthcare:  a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626,  LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365   b) Prodigy Advanced, Model Numbers:  LU42361, LU42397    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.

## Distribution

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Malta, Mexico, Morocco,  Norway, Poland, Portugal , Romania, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab, United Kingdom and Venezuela.

## Key facts

- **Recall number:** Z-1395-2018
- **Recalling firm:** GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-16
- **Report date:** 2018-04-25
- **Termination date:** 2020-12-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Madison, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1395-2018

## Citation

> AI Analytics. FDA recall Z-1395-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1395-2018. Source: US FDA. Licensed CC0.

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