David M. Smith
11-10-2008, 03:47 PM
Date Recall Initiated September 04, 2007
Date Posted June 12, 2008
Recall Number Z-1155-2008
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
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
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.
Date Posted June 12, 2008
Recall Number Z-1155-2008
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
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
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.