Recall Z-0776-2019— GE Healthcare, LLC

Name: FDA recall Z-0776-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-12

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-07-12. It names 2 FDA 510(k) clearances: K163213, K133705. 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: 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.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2018-07-12
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K163213 — Revolution CTGe Medical Systems, LLC·cleared 2016-12-16
K133705 — REVOLUTION CTGe Medical Systems, LLC·cleared 2014-04-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.