Recipient: GE Healthcare Technologies
Product: Diagnostic x-ray system
Date: 1/19/05

Failure to respond constitutes a violation of the Act, Sections 538(a)(2) and 538(a)(4) of Sub-chapter C – Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968). Failure to promptly correct this violation can result in regulatory action being initiated by FDA without further notice. These actions include seizure, injunction, and the imposition of civil penalties as provided for in Section 539 of the Act. Persons violating Section 538 of the Act are subject to civil penalties of up to $1,000 per violation and up to a maximum of $300,000.

FDA District: Minneapolis District Office