Recall Z-1951-2019— GE Healthcare, LLC

Name: FDA recall Z-1951-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-19

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-01-19. It names 2 FDA 510(k) clearances: K163213, K133705. Product: Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.. Reason: Additional low dose radiation exposure..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-01-19
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 scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Reason for recall

Additional low dose radiation exposure.

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