PlainRecordsFDA · Medical device recall
GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO… and 1 more product
- Date posted by the FDA
- March 17, 2011
- Status
- Terminated
- Filed by
- GE Healthcare, LLC
- Reason
- 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.
- Distribution pattern
- Worldwide Distribution
2 products in this recall
GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected usage of this product is…
- 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.
- Quantity
- 112 total
- Codes and lots
- All associated serial numbers.
- Recall started
- July 20, 2010
- Device type
- Full Field Digital, System, X-Ray, Mammographic
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-1043-2011
GE Senographe DS Full Field Mammography System Mammographic Film / Screen System
- Product
- GE SENOGRAPHE DS FULL FIELD MAMMOGRAPHY SYSTEM MAMMOGRAPHIC FILM / SCREEN SYSTEM
- Quantity
- 112 total
- Codes and lots
- All associated serial numbers.
- Recall started
- July 20, 2010
- Device type
- Full Field Digital, System, X-Ray, Mammographic
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-1044-2011
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1043-2011, Z-1044-2011. The agency record governs; check it and the company before acting.