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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmAugust 24, 2004
Date PostedDecember 02, 2004
Recall Status1 Terminated 3 on September 02, 2005
Recall NumberZ-0273-05
Recall Event ID 30420
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
ProductMagnetic Resonance Imaging Systems, under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN
Code Information No specific codes were listed.
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		Software defect causes patient identification number to be truncated.
FDA Determined
Cause 2		Other
ActionFirm issued a letter notifying users of systems that when transferring image data to a DICOM server for any patient born on January 1, to verify that the Patient ID is correct on the DICOM server after the transfer. Firm will modify the software by January 2005.
Quantity in Commerce39 units
DistributionNationwide.
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.
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