Recall Z-1043-2011
GE Healthcare, LLC · initiated July 20, 2010
Product
GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected usage of this product is for the same clinical applications as traditional mammographic film/screen systems. It generates mammographic images which can be used for screening and diagnosis of breast cancer.
Codes / lots: All associated serial numbers.
Reason for recall
It was noticed that 3 units received in Japan were missing the rating plate on the X-ray tube cover. There is a potential that other X-ray tube covers are missing the rating plate.
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
An Important Electronic Product Radiation Warning letter was issued to customers identifying the affected product and describing the defect along with the related hazards. The letter states that there are no actions that are required to be taken on the part of the customer. A GE Healthcare Service Representative will apply the missing rating as necessary and free of charge. Questions or concerns regarding the letter should be directed to 1-800-437-1171 in the US.
Details
- Recall number
- Z-1043-2011
- Initiated
- July 20, 2010
- Posted by FDA
- March 17, 2011
- Terminated
- May 16, 2012
- Product code
- MUE – Full Field Digital, System, X-Ray, Mammographic
- Quantity
- 112 total
- Distribution
- Worldwide Distribution
- Recalling firm
- GE Healthcare, LLC, Waukesha, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1044-2011 | GE SENOGRAPHE DS FULL FIELD MAMMOGRAPHY SYSTEM MAMMOGRAPHIC FILM / SCREEN SYSTEMIt was noticed that 3 units received in Japan were missing the rating plate on the X-ray tube cover. There… | 07/20/2010Terminated |