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Class 2 Device Recall Aplio XG |
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Date Initiated by Firm |
October 02, 2007 |
Date Posted |
January 09, 2008 |
Recall Status1 |
Terminated 3 on April 20, 2012 |
Recall Number |
Z-0305-2008 |
Recall Event ID |
45811 |
510(K)Number |
k063130
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Product Classification |
Diagnostic Ultrasound System - Product Code IYN
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Product |
Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780 |
Code Information |
SERIAL NUMBERS: 99B0752571, 99B0752572, 99B06Z2073, 99B06Z2102, 99B06Z2107, 99B0722268, 99B0722269, 99B0722270, 99B0722271, 99B0722272, 99B0732349, 99B0732350, 99B0732351, 99B0732352, 99B0732353, 99B0732354, 99B0722208, 99B0722250, 99B0752531, 99B0752532, 99B06Z2072, 99B0752508, 99B0752509, 99B0752510, 99B0752511, 99B0722251, 99B06Z2071, 99B0722206, 99B0722207, 99B0722204, 99B0752524, 99B0752525, 99B0732355, 99B0742413, 99B0742414, 99B0742415, 99B0742416, 99B0742417, 99B0722203, 99B06Z2062, 99B0722201, 99B0712171, 99B0722254, 99B0752507, 99B06Z2064, 99B06Z2104, 99B0712169, 99B0712172, 99B0722202, 99B0752570, 99B0752562, 99B0752563, 99B0752564, 99B0752565, 99B06Z2103, 99B0752523, 99B0752550, 99B06Z2074, 99B0712173, 99B0712174, 99B06Z2059, 99B0752551, 99B0752561, 99B06Z2108, 99B0752549, 99B0722205, 99B0752547, 99B0712168, 99B0722253, 99B06Y2048, 99B06Y2049, 99B06Y2051, 99B06Z2058, 99B06Z2067, 99B06Z2110, 99B06Z2116, 99B06Z2057, 99B06Z2088, 99B06Z2105, 99B06Z2111, 99B06Z2115, 99B0722252, 99B06Z2063, 99B06Z2065, 99B06Z2066, 99B06Z2090, 99B06Z2101, 99B06Z2113, 99B0712170, 99B06Z2060, 99B06Z2068, 99B06Z2070, 99B06Z2106, 99B0752548, 99B06Z2089, 99B06Z2091, 99B06Z2092, 99B06Y2050, 99B06Z2055, 99B06Z2056, 99B06Z2061, 99B06Z2069, 99B06Z2075, 99B06Z2109, 99B06Z2112, and 99B06Z2114 |
Recalling Firm/ Manufacturer |
Toshiba American Med Sys Inc 2441 Michelle Dr P.O. Box 2068 Tustin CA 92781-2068
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For Additional Information Contact |
Paul Biggins 714-730-5000
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Manufacturer Reason for Recall |
Panel Lock-up: When using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. If the panel locks up the system will have to be rebooted to continue the examination which may cause a delay in completion of the patient examination.
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FDA Determined Cause 2 |
Software design |
Action |
Notification letters, Urgent Medical Device Correction, with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.--A short term instruction included "Avoid using the Freeze Key when performing dynamic image acquisitions" |
Quantity in Commerce |
69 |
Distribution |
Nationwide: USA including the states of AK, AZ, CA, FL, IA, IL, IN, KS, MI, MN, MO, MT, NE, NV, NY, OH, OR, PR, VA, WI & WV |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = IYN and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION
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