• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Aplio Artida Ultrasound Diagnostic System SSH880CV

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Aplio Artida Ultrasound Diagnostic System SSH880CV
see related information
Date Posted July 29, 2011
Recall Status1 Terminated on April 20, 2012
Recall Number Z-2897-2011
Recall Event ID 57856
Premarket Notification
510(K) Number
K090158 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc. A diagnostic ultrasound system.
Code Information Last 4 of serial number: 2342, 2480, 2073, 2120, 2219, 2270, 2271, 2268, 2389, 2390, 2297, 2206, 2033, 2107, 2087, 2311, 2281, 2273, 2340, 2341, 2313, 2272, 2070, 2335, 2347, 2348, 2360, 2361, 2048, 2280, 2031, 2088, 2076, 2077, 2105, 2334, 2220, 2260, 2205, 2072, 2074, 2079, 2218, 2103, 2262, 2069, 2106, 2119, 2124, 2204, 2405, 2104, 2032, 2075, 2080, 2108, 2261, 2312, 2078, 2071, 2123, 2296, 2282, 2049, and 2056.
Recalling Firm/
Manufacturer
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92781-2068
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Toshiba America Medical Systems, Inc. is initiating a field correction on the Aplio Artida Ultrasound Diagnostic System because the panel operation for the Aplio Artida may become disabled (i.e., system may hang up) when processing to display patient information (heart rate, time, VCP counter, ect.).
FDA Determined
Cause 2
DESIGN: Software Design
Action Toshiba America Medical Systems, Inc. sent out an "Urgent Medical Device Correction" dated December 21, 2010 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were notified that Toshiba will issue a field modification to correct the software, and if the problem occurs, they were instructed to shutdown the system holding down the power supply button for 5 seconds for 5 seconds and then restart the system. A form to send back to Toshiba is included. For questions on this recall call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.
Quantity in Commerce 46 units
Distribution Worldwide Distribution: (USA) Nationwide distribution including the states of MD, OH, PA, NY, MA, GA, AL, TX, IL, WI, IA, MN, KY, MT, OR, LA, and CA; and the country of Puerto Rico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
-
-