High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system.
FDA device recall Z-0198-06 · posted 2005-11-24 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- 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.
- Action taken
- Consignees notification that a local TAMS service representative will schedule the implementation of the replacement transformer.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 30
- Distribution
- CA, CO, KS, IL, LA, IN, ME, MI, NC, NJ, NY, OH, PA, TX
- Date initiated
- 2005-09-21
- Date posted
- 2005-11-24
- Date terminated
- 2007-07-12
- Location
- Tustin, CA
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