DPX-Bravo/Duo, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD.
This recall has been terminated (originally issued January 27, 2010).
- Company
- Ge Healthcare
- Recall Initiated
- February 1, 2009
- Posted
- January 27, 2010
- Terminated
- December 31, 2011
- Recall Number
- Z-0604-2010
- Quantity
- 1,764 total
- Firm Location
- Wauwatosa, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Failure to properly pre-indicate the technique factors to be used during a patient scan.
Distribution
Nationwide Distribution
Lot / Code Info
software versions 12.0, 12.1, 12.2,13.0, & 13.1.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
An Important Electronic Product Radiation Warning letter will be sent to customers. The letter will discuss the defect description and related hazards, the affected product details, safety instructions, and product correction. Customers are to contact their local GE Healthcare service representative with questions.
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