FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0849-04
- Recalling firm
- USA Instruments Inc.
- 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.
- Status
- Terminated
- Initiated
- 2004-03-19
- Posted
- 2004-07-20
- Terminated
- 2012-03-01
- 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.
- Lot, serial or model codes
- USAI P/N: 100352, USAI S/Ns: 310 to 388 (Rev 1 and 2); Siemens P/N: 7578789, Siemens S/Ns: 1010 to 1088.
- 510(k) numbers
- ["K030371"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3005214683
- Firm city
- Aurora
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28