Recall Z-0849-04 ยท LNH System, Nuclear Magnetic Resonance Imaging
USA Instruments Inc.
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.
| Date | Jul 20, 2004 (initiated Mar 19, 2004) |
| Status | Terminated |
| Reason | A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's body. |
| Root cause | Other |
| Action | 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. |
| Quantity | 79 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030371 | PRIMA III TOTALSENSE TORSO COIL Usa Instruments, Inc., May 5, 2003 |