Recall Z-1900-2021— GE Healthcare, LLC

Name: FDA recall Z-1900-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-14

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-06-14. It names one FDA 510(k) clearance: K131576. Product: Revolution EVO, Optima CT660, Optima CT680 CT Systems.. Reason: Improperly loaded software options may result in additional X -ray radiation exposure to the patient..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-06-14
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K131576 — OPTIMA CT660Ge Medical Systems, LLC·cleared 2013-08-30

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 EVO, Optima CT660, Optima CT680 CT Systems.

Reason for recall

Improperly loaded software options may result in additional X -ray radiation exposure to the patient.

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