GE Healthcare Clinical Systems
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What GE Healthcare Clinical Systems makes
The company manufactures the LULLABY, a neonatal patient monitoring device designed for continuous vital sign assessment in intensive care settings, including heart rate, respiratory rate, and oxygen saturation.
The LULLABY falls under FDA Class II regulation and is listed via the 510(k) clearance pathway. The company operates from the United States.
Catalogue
Lullaby Ref K071828
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Ge Healthcare Clinical Systems, initiated on 2007-09-04. By recorded status: 1 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 4 Sep 2007 Z-1155-2008 Unclassified (pre-2012) Terminated 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
Full distribution text
- 4 Sep 2007 Z-1155-2008 Unclassified (pre-2012) Terminated 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
Frequently asked questions
How many devices does Ge Healthcare Clinical Systems have in the registry?
The registry currently lists 1 device for Ge Healthcare Clinical Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ge Healthcare Clinical Systems's devices?
Among its 1 most recently registered device, Ge Healthcare Clinical Systems has devices listed in FDA 510(k) (1 device).
What risk classes do Ge Healthcare Clinical Systems's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ge Healthcare Clinical Systems's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ge Healthcare Clinical Systems?
FDA recall records list 1 recall initiated by Ge Healthcare Clinical Systems, the most recent initiated on 4 Sep 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ge Healthcare Clinical Systems in the registry?
The most recently registered devices listed for Ge Healthcare Clinical Systems include LULLABY.