Device Recall Prima III TotalSENSE Torso Coil, a Magnetic Imaging Accessory

USAI P/N: 100352, USAI S/Ns: 310 to 388 (Rev 1 and 2); Siemens P/N: 7578789, Siemens S/Ns: 1010 to 1088.

Radiology Devices

2

No

The device was shipped to domestic consignees located CT, NY, PA, NC, GA, FL, OH, IN, MN, IL, UT, CA, OR; and foreign consignees in Austria, Denmark, Spain, Hong Kong, China, Netherlands, Japan, Taiwan, Korea, Australia, Turkey, Brazil, Germany.

Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA Instruments, Inc. This device is a component of the Magnetom TRIO 3.0T MRI Systems, manufactured by Siemens AG Medical Solutions.