Z-0198-06

High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system

Name: Z-0198-06 High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system
Creator: Toshiba American Med Sys Inc
Published: 2005-09-21
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2005-09-21 / Terminated

FDA source

Toshiba American Med Sys Inc began a recall of High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system on 2005-09-21. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0198-06
Status: Terminated
Initiated: 2005-09-21
Posted: 2005-11-24
Terminated: 2007-07-12
Recalling firm: Canon Medical Systems USA, Inc.
Product: High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: 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.
FDA root cause: Other
Action: Consignees notification that a local TAMS service representative will schedule the implementation of the replacement transformer.
Quantity in commerce: 30
Distribution: CA, CO, KS, IL, LA, IN, ME, MI, NC, NJ, NY, OH, PA, TX
Product codes and lots: model numbers: XTP-8100G AND XTBP-8100G

Product code JAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)