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U.S. Department of Health and Human Services

Class 2 Device Recall GE LOGIQ 3 Expert

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  Class 2 Device Recall GE LOGIQ 3 Expert see related information
Date Initiated by Firm September 04, 2007
Date Posted June 12, 2008
Recall Status1 Terminated 3 on May 29, 2012
Recall Number Z-1155-2008
Recall Event ID 44884
510(K)Number K020263  
Product Classification ultrasound scanner - Product Code IYN
Product GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201
Code Information Systems with software version 4.0.5, 4.1.1 and 4.1.2. Serial numbers: 26022WS4, 26023WS2, 26346WS7, 2641WS8, 31001WS1, 34381WS4, 36460WS4, 36461WS2, 43734WS3, 43735WS0, 43736WS8, 43737WS6, 43994WS3, 43995WS0, 43998WS4, 44000WS8, 44001WS6, 44002WS4, 44003WS2, 44004WS0, 44005WS7, 44011WS5, 44012WS3, 44013WS1, 44015WS6, 44016WS4, 44018WS0, 44019WS8, 44020WS6, 44100WS6, 44153WS5, 44157WS6, 44159WS2, 44270WS7, 44273WS1, 44274WS9, 44275WS6, 44276WS4, 44277WS2, 44532WS0, 44533WS8, 44817WS5, 44819WS1, 44820WS9, 44821WS7, 44822WS5, 44825WS8, 44826WS6, 44908WS2, 44909WS0, 44912WS4, 44914WS0, 44915WS7, 44989WS2, 44990WS0, 44991WS8, 44992WS6, 44994WS2, 45088WS2, 45089WS0, 5122WS7
Recalling Firm/
Manufacturer		 GE Healthcare Clinical Systems
Manufacturer Reason
for Recall		 Inaccurate guidelines: The BE9C is an optional, small radius Bi-planar convex probe intended for use with the LOGIQ 3 Expert system in Urology application. An attempt by the user to activate the biopsy guidelines while this probe is in use will cause incorrect guidelines to be displayed on the image. The incorrect guidelines are recognized by their orientation that is left/right reversed from t
FDA Determined
Cause 2		 Software change control
Action GE sent consignees a "GE Urgent Medical Device Correction" letter dated 8/14/07. The letter informed the customers about the problem, offer a short-term workaround and informed them that a representative will schedule a visit to upgrade the software.
Quantity in Commerce 62
Distribution Worldwide Distribution - USA (NY & AL), Korea, China, India, Brazil, Mexico, Germany, Greece, Italy, Poland, Russia, Saudi Arabia, Spain, and Czech Republic.
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.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = GENERAL ELECTRIC CO.
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