RecallDepth

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

Company
Toshiba American Med Sys Inc
Recall Initiated
September 21, 2005
Posted
November 24, 2005
Terminated
July 12, 2007
Recall Number
Z-0198-06
Quantity
30
Firm Location
Tustin, CA

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.

Distribution

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

Lot / Code Info

model numbers: XTP-8100G AND XTBP-8100G

Root Cause

Other

Action Taken

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

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