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U.S. Department of Health and Human Services

Class 2 Device Recall Nemio XG SSA580A, Diagnostic Ultrasound System

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 Class 2 Device Recall Nemio XG SSA580A, Diagnostic Ultrasound Systemsee related information
Date Initiated by FirmDecember 19, 2006
Date PostedMay 05, 2007
Recall Status1 Terminated 3 on February 15, 2012
Recall NumberZ-0771-2007
Recall Event ID 37813
510(K)NumberK061605 
Product Classification Diagnostic Ultrasound System - Product Code ITX
ProductNemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical Systems, Inc., Tusin, CA.
Code Information Serial #: A1A0642100; A1A0642102; A1B0662183; A1B0662184; A1B0662256; A1B0662257; A1B0662258; A1B0662327; A1B0662328; A1B0662330; A1B0662331; A3A0652115; A3B0662284; A3B0662285; A3B0662286; A3B0662287; A3B0662288; A3B0662289; A3B0662290; A3B0662291; A3B0662292; A3B0662293; A3B0662371; A3B0662372; A3B0662373; A3B0662374; A3B0662375; A3B0662376; A3B0662377; A3B0662378; A3B0662379; A3B0662380; A3B0672415; A3B0672416; A3B0672417; A3B0672418; A3B0672419;
Recalling Firm/
Manufacturer		 Toshiba American Med Sys Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92781-2068
For Additional Information ContactPaul Biggins
714-730-5000
Manufacturer Reason
for Recall		Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature could exceed the 27 degrees Celsius limit as specified in the IEC safety standard.
FDA Determined
Cause 2		Other
ActionNotification letters were sent to customers on December 19, 2206. Customers were instructed to avoid using Scale Graph function with live images, and instructed to call up the Scale Graph after images are frozen. Customers were informed that a Toshiba Customer Service Engineer will contact them to schedule a software upgrade when software becomes available. If customers have any questions they were instructed to contact their Toshiba Customer Service Engineer or call (800) 421-1968 and ask for the Regulatory Affairs Department. Customers were also instructed to distribute this information to all users of the product and also with the Bio-medical Department at their facility.
Quantity in Commerce37
DistributionNationwide Distribution including the states of CA, FL, GA, ID, MA, MN, NC, NY, PA, RI, TN, TX, WA, and WI.
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 = ITX
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