PlainRecordsFDA · Medical device recall
iDXA… and 4 more products
- Date posted by the FDA
- Jan. 27, 2010
- Status
- Terminated
- Filed by
- Ge Healthcare
- Reason
- Failure to properly pre-indicate the technique factors to be used during a patient scan.
- Distribution pattern
- Nationwide Distribution
5 products in this recall
iDXA…
- Product
- iDXA, 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
- Quantity
- 1,764 total
- Codes and lots
- software versions 12.0, 12.1, 12.2,13.0, & 13.1.
- Recall started
- Feb. 1, 2009
- Device type
- Densitometer, Bone
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0600-2010
Prodigy 1-8 series…
- Product
- Prodigy 1-8 series, 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
- Quantity
- 1,764 total
- Codes and lots
- software versions 12.0, 12.1, 12.2,13.0, & 13.1.
- Recall started
- Feb. 1, 2009
- Device type
- Densitometer, Bone
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0601-2010
DPX-NT series…
- Product
- DPX-NT series, 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.
- Quantity
- 1,764 total
- Codes and lots
- software versions 12.0, 12.1, 12.2,13.0, & 13.1.
- Recall started
- Feb. 1, 2009
- Device type
- Densitometer, Bone
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0602-2010
DPX-MD series…
- Product
- DPX-MD series, 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.
- Quantity
- 1,764 total
- Codes and lots
- software versions 12.0, 12.1, 12.2,13.0, & 13.1.
- Recall started
- Feb. 1, 2009
- Device type
- Densitometer, Bone
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0603-2010
DPX-Bravo/Duo…
- Product
- 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.
- Quantity
- 1,764 total
- Codes and lots
- software versions 12.0, 12.1, 12.2,13.0, & 13.1.
- Recall started
- Feb. 1, 2009
- Device type
- Densitometer, Bone
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0604-2010
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0600-2010, Z-0601-2010, Z-0602-2010, Z-0603-2010, Z-0604-2010. The agency record governs; check it and the company before acting.