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.
- Company
- Usa Instruments Inc.
- Recall Initiated
- March 19, 2004
- Posted
- July 20, 2004
- Terminated
- March 1, 2012
- Recall Number
- Z-0849-04
- Quantity
- 79
- Firm Location
- Aurora, OH
Reason for Recall
A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's body.
Distribution
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.
Lot / Code Info
USAI P/N: 100352, USAI S/Ns: 310 to 388 (Rev 1 and 2); Siemens P/N: 7578789, Siemens S/Ns: 1010 to 1088.
Root Cause
Other
Action Taken
The firm notified the regional Siemens Service Centers by letter on 3/19/2004. The affected coils will be returned to the recalling firm for modification.