FDA recall Z-0776-2019

GE Healthcare, LLC · Class II · device

Product

Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Reason for recall

On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator

Distribution

Worldwide Distribution - US (Nationwide Distribution) and countries of: Australia, Belgium, Canada, Estonia, Finland, France, Germany, Hong Kong, Ireland, Japan, Korea Republic of, Malaysia, Morocco, New Zealand, Norway, Saudi Arabia, Singapore, Slovakia, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.

Key facts

Status
Ongoing
Initiation date
2018-07-12
Report date
2019-02-13
Voluntary/Mandated
FDA Mandated
Location
Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0776-2019