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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 23, 2005
Date Posted July 13, 2005
Recall Status1 Terminated 3 on May 10, 2012
Recall Number Z-0982-05
Recall Event ID 32387
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001 and 6.0er002
Code Information Software versions 6.0er001 and 002
Recalling Firm/
Manufacturer		 Toshiba American Med Sys Inc
2441 Michelle Dr
Tustin CA 92781
For Additional Information Contact Paul Biggins
714-730-5000
Manufacturer Reason
for Recall		 If the measurement mode is started from the Doppler mode and then the sweep speed setting is changed by the assigned user function, the measurement of the time direction results don't correspond to the actual values.
FDA Determined
Cause 2		 Other
Action Firm issued a recall letter which provided a procedural workaround, a software patch will be installed during routine service visits.
Quantity in Commerce 106
Distribution Nationwide. This is an imported product.
Total Product Life Cycle TPLC 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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