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Class 2 Device Recall Prodigy 18 series |
 |
| Date Initiated by Firm |
February 01, 2009 |
| Date Posted |
January 27, 2010 |
| Recall Status1 |
Terminated 3 on December 31, 2011 |
| Recall Number |
Z-0601-2010 |
| Recall Event ID |
53692 |
| Product Classification |
Bone Densitometer - Product Code KGI
|
| 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 |
| Code Information |
software versions 12.0, 12.1, 12.2,13.0, & 13.1. |
Recalling Firm/
Manufacturer |
Ge Healthcare
9900 W Innovation Dr
Wauwatosa WI 53226-4856
|
Manufacturer Reason
for Recall |
Failure to properly pre-indicate the technique factors to be used during a patient scan.
|
FDA Determined
Cause 2 |
Radiation Control for Health and Safety Act |
| Action |
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. |
| Quantity in Commerce |
1,764 total |
| Distribution |
Nationwide Distribution |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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