GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected usage of this product is for the sa

FDA device recall Z-1043-2011 · posted 2011-03-17 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

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.

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

MUE

Quantity affected

112 total

Distribution

Worldwide Distribution

Date initiated

2010-07-20

Date posted

2011-03-17

Date terminated

2012-05-16

Location

Waukesha, WI