Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490
- Company
- Toshiba American Med Sys Inc
- Recall Initiated
- October 12, 2005
- Posted
- December 14, 2005
- Terminated
- July 12, 2007
- Recall Number
- Z-0281-06
- Quantity
- 65
- Firm Location
- Tustin, CA
Reason for Recall
To correct a hardware problem of water leakage in the cooling system inside the ASGC, leading to the replacement of the gradient coil.
Distribution
Nationwide
Lot / Code Info
Serial Numbers: A4622037, A4612031, A4622017, A4532013, A4582010, A5532048, A4592013, A4532012, A5532022, A4602028, A3592003, A4522007, A5512041, A4612015, A4572020, A4602029, A4622039, A4612030, A4542015, A4602014, A4602026, A4622036, A5522045, A5532047, A4612033, A5512040, A4612032, A4562003, A4572004, A4592012, A4562018, A4622035, A4522009, A4602025, A3582001, A5512043, A45320 11, A4602024, A5512018, A4572006, A4572023, A5512019, A5532049, A3592002, A4602027, A4552002, A4512006, A4552017, A5522046, A4572005, A4562019, A4572021, A4522008, A4612034, A4582009, A3612004, A4622016, A4532010, A3622001, A5512044, A4552016, A4572007, A4592011, A4572008, & A5512042
Root Cause
Other
Action Taken
Toshiba America Medical Systems, Inc., (TAMS) customer service engineers will hand deliver The Advisory Letter and monitor the system during their monthly preventive maintenance.