DPX-Bravo/Duo, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. T
FDA device recall Z-0604-2010 · posted 2010-01-27 · Terminated
Recall details
- Recalling firm
- Ge Healthcare
- Reason for recall
- Failure to properly pre-indicate the technique factors to be used during a patient scan.
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- KGI
- Quantity affected
- 1,764 total
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-02-01
- Date posted
- 2010-01-27
- Date terminated
- 2011-12-31
- Location
- Wauwatosa, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.