GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL) The Senographe Essential system is intended to be

FDA device recall Z-1041-2011 · posted 2011-03-18 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

During installation it was discovered that the duplicate of the 21 CFR 1010 Certification label for the X-ray Generator Cabinet was missing from the installation kits that allow installation of the Senographe Essential in a van (mobile unit).

Action taken

The firm plans to repair the defect or to bring product into compliance. The field action is being implemented to inspect the affected units and if found to be missing the certification label, a certification label will be applied. This will be carried out via a Field Modification Instruction planned to be released in March, 2011 with an estimated completion date of July, 2011.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

MUE

Quantity affected

14

Distribution

Nationwide Distribution

Date initiated

2011-01-19

Date posted

2011-03-18

Date terminated

2012-05-16

Location

Waukesha, WI