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, Milwauke
FDA device recall Z-1155-2008 · posted 2008-06-12 · Terminated
Recall details
- Recalling firm
- 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 taken
- 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.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 62
- Distribution
- Worldwide Distribution - USA (NY & AL), Korea, China, India, Brazil, Mexico, Germany, Greece, Italy, Poland, Russia, Saudi Arabia, Spain, and Czech Republic.
- Date initiated
- 2007-09-04
- Date posted
- 2008-06-12
- Date terminated
- 2012-05-29
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LOGIQ 3 (K020263) | General Electric Co. | 2002-02-06 |