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.
FDA Recall Z-0849-04 · Posted 2004-07-20
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Recalling FirmUSA Instruments Inc.
Recall StatusTerminated
Product CodeLNH
Date Initiated2004-03-19
Date Terminated2012-03-01
Product Quantity79
Reason for Recall
A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's body.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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