Z-0849-04

Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA Instruments, Inc. This...

Name: Z-0849-04 Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA Instruments, Inc. This...
Creator: USA Instruments Inc.
Published: 2004-03-19
License: https://open.fda.gov/license/

GE Healthcare Coils / initiated 2004-03-19 / Terminated

FDA source

USA Instruments Inc. began a recall of 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... on 2004-03-19. The reason FDA records is "A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's body". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0849-04
Status: Terminated
Initiated: 2004-03-19
Posted: 2004-07-20
Terminated: 2012-03-01
Recalling firm: GE Healthcare Coils
Product: 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.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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 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 in commerce: 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.
Product codes and lots: USAI P/N: 100352, USAI S/Ns: 310 to 388 (Rev 1 and 2); Siemens P/N: 7578789, Siemens S/Ns: 1010 to 1088.

Product code LNH

K030371Class IIPrima III Totalsense Torso CoilUsa Instruments, Inc. / cleared 2003-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)