Recall Z-0608-2019— GE Healthcare, LLC

Name: FDA recall Z-0608-2019
Creator: U.S. Food and Drug Administration
Published: 2018-05-24

Class II · Completed

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-05-24. It names one FDA 510(k) clearance: K093514. Product: Discovery NM/CT 670 Pro, model 5376204-70-54. Reason: When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Completed
Initiated: 2018-05-24
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K093514 — DISCOVERY MODEL NM/CT 670Ge Medical Systems F.I. Haifa·cleared 2009-12-10

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

Discovery NM/CT 670 Pro, model 5376204-70-54

Reason for recall

When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard.

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