Recall Z-1753-2019— GE Healthcare, LLC

Name: FDA recall Z-1753-2019
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 one FDA 510(k) clearance: K790692. Product: Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.. 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

1 on FDA's record

K790692 — TELEVIXGeneral Electrical Espanola, S.A.·cleared 1979-04-23

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

Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.

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.