Recall Z-2583-2018— GE Healthcare, LLC

Name: FDA recall Z-2583-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-24

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-05-24, terminated 2019-02-08. It names 2 FDA 510(k) clearances: K131576, K110227. Product: CT Goldseal Optima CT 600. Reason: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply)..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-05-24
Terminated: 2019-02-08
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

CT Goldseal Optima CT 600

Reason for recall

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

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