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Terminated

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

FDA Recall Z-0198-06 · Posted 2005-11-24

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2005-09-21
Date Terminated2007-07-12
Product Quantity30

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.

Firm Action

Consignees notification that a local TAMS service representative will schedule the implementation of the replacement transformer.

Root Cause

Other

Distribution Pattern

CA, CO, KS, IL, LA, IN, ME, MI, NC, NJ, NY, OH, PA, TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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