Recall Z-1754-2019— GE Healthcare, LLC

Name: FDA recall Z-1754-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-29

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-03-29, terminated 2021-04-15. It names 2 FDA 510(k) clearances: K081091, K011624. Product: Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.. Reason: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-03-29
Terminated: 2021-04-15
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

2 on FDA's record

K081091 — PRECISION 500D R&F X-RAY SYSTEMGE Healthcare·cleared 2008-06-11
K011624 — EXPEDIO 500D R&F X-RAY SYSTEMGE Medical Systems·cleared 2001-06-08

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

Precision 500D The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations.

Reason for recall

There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.

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