Recall Z-2123-2015— GE Healthcare

Name: FDA recall Z-2123-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-12

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2015-06-12, terminated 2017-08-03. It names one FDA 510(k) clearance: K033486. Product: GE Healthcare, Precision MPi fluoroscopic imaging systems.. Reason: A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems..

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2015-06-12
Terminated: 2017-08-03
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K033486 — GE PRECISION MPINrt-Nordisk Rontgen Teknik A/S·cleared 2003-11-19

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, Precision MPi fluoroscopic imaging systems.

Reason for recall

A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems.

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