GE Healthcare Clinical Systems
Laurel, MD, US
Ge Healthcare Clinical Systems appears in FDA device records in Laurel, MD. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for GE Healthcare Clinical Systems in 2007.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 414, Milwaukee, Wisconsin 53201 | 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 | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain