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U.S. Department of Health and Human Services

Class 2 Device Recall Prima III TotalSENSE Torso Coil, a Magnetic Imaging Accessory

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 Class 2 Device Recall Prima III TotalSENSE Torso Coil, a Magnetic Imaging Accessorysee related information
Date Initiated by FirmMarch 19, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on March 01, 2012
Recall NumberZ-0849-04
Recall Event ID 28693
510(K)NumberK030371 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
ProductPrima 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.
Code Information USAI P/N: 100352, USAI S/Ns: 310 to 388 (Rev 1 and 2); Siemens P/N: 7578789, Siemens S/Ns: 1010 to 1088.
FEI Number 3005214683
Recalling Firm/
Manufacturer		 USA Instruments Inc.
1515 Danner Dr
Aurora OH 44202-9273
For Additional Information Contact
330-995-8572
Manufacturer Reason
for Recall		A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's body.
FDA Determined
Cause 2		Other
ActionThe 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 in Commerce79
DistributionThe 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = LNH
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