Devices

Device Recall Hologic Oasis Bone Densitometers

Model / Serial
S/N: 11/01/06 B 1/04/08B 11/01/06 A 6/24/05-A 9/25/06-01 9/25/06-02 9/25/06-03 9/25/06-04 9/28/06-01 9/28/06-02 9/28/06-03 9/12/07B 10/02/07B 10/02/07A and 1/04/08A
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Foreign: Canada Algeria, AE, Australia, Belgium,China,France, Germany, Hungary, Hong Kong, Iceland, Iran, Ireland, Israel, Italy,Japan,Korea, Kuwait, Lithuania, Mexico, Myanmar, Netherlands, Pakistan, Peru, Russia, S. Africa, Saudi Arabia, Singapore, Slovak Rep., Switzerland, Syria, Taiwan, UK
Product Description
Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
Manufacturer
Hologic, Inc.
1 Event
- Recall of Device Recall Hologic Oasis Bone Densitometers

Manufacturer

Hologic, Inc.

Manufacturer Address
Hologic, Inc., 35 Crosby Dr, Bedford MA 01730-1450
Manufacturer Parent Company (2017)
Hologic Inc
Source
USFDA

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