Siemens Gets Two Warning Letters in Two Months

The FDA has sent Siemens Medical Solutions a warning for violations related to the company’s molecular imaging diagnostic equipment.

This warning is the second the company has received in as many months. In December, the company’s ultrasound division received a letter saying marketing for several products went beyond the scope of their cleared indications.

The latest letter said the devices are adulterated, and the company failed to correct and prevent the recurrence of nonconforming product and other quality problems.

At least four complaints were received concerning positron emission tomography (PET) and computed technology (CT) scans linked to the wrong patient, the letter said. In addition, no risk analysis was performed for complaints on incorrect normalization values in certain PET/CT scanners.

The warning letter can be seen at www.fda.gov/foi/warning_letters/s6655c.pdf.