Recall Z-1155-2008 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Healthcare Clinical Systems
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
| Date | Jun 12, 2008 (initiated Sep 4, 2007) |
| Status | Terminated |
| Reason | 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 | 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 | 62 |
| Distribution | Worldwide Distribution - USA (NY & AL), Korea, China, India, Brazil, Mexico, Germany, Greece, Italy, Poland, Russia, Saudi Arabia, Spain, and Czech Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020263 | LOGIQ 3 General Electric Co., Feb 6, 2002 |