Z-1155-2008

GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2. GE Healthcare P.O. Box...

Name: Z-1155-2008 GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2. GE Healthcare P.O. Box...
Creator: GE Healthcare Clinical Systems
Published: 2007-09-04
License: https://open.fda.gov/license/

GE Healthcare Clinical Systems / initiated 2007-09-04 / Terminated / root cause: software

FDA source

GE Healthcare Clinical Systems began a recall of 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 on 2007-09-04. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1155-2008
Status: Terminated
Initiated: 2007-09-04
Posted: 2008-06-12
Terminated: 2012-05-29
Recalling firm: GE Healthcare Clinical Systems
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
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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

Product code IYN

K020263Class IILogiq 3General Electric Co. / cleared 2002-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)