Devices

Device Recall GE Healthcare Prodigy; Prodigy Advanced

Model / Serial
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
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
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.
Product Description
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.
Manufacturer
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
1 Event
- Recall of Device Recall GE Healthcare Prodigy; Prodigy Advanced

Manufacturer

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Manufacturer Address
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, 3030 Ohmeda Dr, Madison WI 53718-6704
Manufacturer Parent Company (2017)
General Electric Company
Source
USFDA

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