Marketing for several Siemens Medical Solutions products went beyond the scope of the cleared indications for the devices, making them adulterated, according to an FDA warning letter.
The Dec. 17, 2007, letter cited product information for the company’s syngo Arterial Health Package (AHP) and syngo US Workplace following an Office of Compliance review of website statements, a brochure and press releases for the devices.
A review of FDA records showed Siemens did not have marketing approval or clearance for the AHP when it marketed the product for use with its ultrasound systems and syngo US Workplace.
The FDA requested that Siemens cease distribution of the syngo AHP and dissemination of materials promoting uncleared use of the AHP with certain ultrasound systems and the syngo US Workplace.
Siemens said it is cooperating with the FDA and has removed the information from its website.
The warning letter can be seen at www.fda.gov/foi/warning_letters/s6605c.pdf.