Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA Instruments, Inc. This device is a co
FDA device recall Z-0849-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- USA Instruments Inc.
- Reason for recall
- A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's body.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 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, Taiwa
- Date initiated
- 2004-03-19
- Date posted
- 2004-07-20
- Date terminated
- 2012-03-01
- Location
- Aurora, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMA III TOTALSENSE TORSO COIL (K030371) | Usa Instruments, Inc. | 2003-05-05 |