High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system.
This recall has been terminated (originally issued November 24, 2005).
- 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
- Official Source
- View on FDA website ↗
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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