FDA Device

Seneographe 2000D Digital Mammography X-Ray System

Hazard

The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.

What You Should Do

Remedy

The consignees were sent 'Regulatory Notice' letters dated February 6, 2004. The letters informed the consignees of the violations and provided them with the technical specifications which needed to be provided.

Products

Seneographe 2000D Digital Mammography X-Ray System
Brand
General Electric Med Systems
UPC
All serial numbers