Toshiba American Med Sys Inc High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system.
Brand
Toshiba American Med Sys Inc
Lot Codes / Batch Numbers
model numbers: XTP-8100G AND XTBP-8100G
Products Sold
model numbers: XTP-8100G AND XTBP-8100G
Toshiba American Med Sys Inc is recalling High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consignees notification that a local TAMS service representative will schedule the implementation of the replacement transformer.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, IL, IN, KS, LA, ME, MI, NJ, NY, NC, OH, PA, TX
Page updated: Jan 10, 2026