FDA Medical Device Recalls (openFDA)
Toshiba American Med Sys Inc: High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system.
- Recall number
- Z-0198-06
- Recalling firm
- Toshiba American Med Sys Inc
- Product
- High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system.
- Status
- Terminated
- Initiated
- 2005-09-21
- Posted
- 2005-11-24
- Terminated
- 2007-07-12
- Reason
- It was found during a study, arcing might occur in the transformer of the high voltage generator, XTP-8100G and XTBP-8100G displaying an error message and interrupting fluoroscopy.
- Root cause
- Other
- Action
- Consignees notification that a local TAMS service representative will schedule the implementation of the replacement transformer.
- Quantity
- 30
- Distribution
- CA, CO, KS, IL, LA, IN, ME, MI, NC, NJ, NY, OH, PA, TX
- Lot, serial or model codes
- model numbers: XTP-8100G AND XTBP-8100G
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- 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