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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmSeptember 16, 2004
Date PostedNovember 02, 2004
Recall Status1 Terminated 3 on July 13, 2005
Recall NumberZ-0061-05
Recall Event ID 30152
510(K)NumberK032490 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
ProductExcelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System,
Code Information Serial numbers: A4512006, A452017, A4532011, A3612004, A4532014, A4572020, A4572021, A3622005, A4562003, A3592003, A4562018, A4522008, A4532010, A4542015, A4532013, A3622001, A3582001, A4522009, A4532012, A3592002, A4522007, A4552016.
FEI Number 2020563
Recalling Firm/
Manufacturer		 Toshiba American Med Sys Inc
2441 Michelle Dr
Tustin CA 92781
For Additional Information ContactMichaela Mahl
714-730-5000
Manufacturer Reason
for Recall		Scanned images are acquired at a position that is shifted relative to the intended position in the slice direction due to a software anomaly.
FDA Determined
Cause 2		Other
ActionFirm issued a letter to users on 9/29/2004 which includes a method to avoid the software problem until it can be corrected by an update.
Quantity in Commerce22
DistributionPA, MD, FL, OH, NY, CA, AR, KY, OK, AZ, TX, NV, IN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LNH
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