Reported Apr 25, 2018 · Terminated
GE Healthcare
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL · 3030 Ohmeda Dr · Madison, WI · 53718-6704
Is this the product you have?
GE Healthcare
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced |
| 2 | 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 |
| 3 | reference population at the sole discretion of the physician. |
- Lot codes and dates
- a) Prodigy
- Model Numbers
LU7248LU8905LU40427LU40431LU40626LU40637LU40626LU40637LU42021LU42025LU41730LU41734LU42344LU42365 b) Prodigy Advanced
- Model Numbers
LU42361LU42397
- Amount recalled
- 303 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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