BRAVO

Model: FGS-0312 (5 pack) and FGS-0313 (1 pack), Affected:

md

a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692

Radiology Devices

2

No

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.

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.

All serial numbers less than 400,000 are involved.

Gastroenterology-Urology Devices

1

No

The devices were distributed nationwide in the United States and worldwide.

Bravo pH Monitoring System Receiver