Recall Z-2182-2017— GE Healthcare, LLC

Name: FDA recall Z-2182-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-19

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2017-05-19, terminated 2018-07-29. It names 2 FDA 510(k) clearances: K131576, K110227. Product: GE Healthcare Optima CT660, CT680 X-ray system. Reason: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-05-19
Terminated: 2018-07-29
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K131576 — OPTIMA CT660Ge Medical Systems, LLC·cleared 2013-08-30
K110227 — OPTIMA CT660Ge Medical Systems, LLC·cleared 2011-07-20

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

GE Healthcare Optima CT660, CT680 X-ray system

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

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