GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-0776-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 12, 2018

Date Posted: February 13, 2019

Recall Number: Z-0776-2019

Event ID: 81922

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

Status: Ongoing

Product Quantity: 131 units

Code Information:

SmartStep Option

Distribution Pattern:

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.

Voluntary or Mandated:

FDA Mandated