Recall Z-0813-2013— GE Healthcare, LLC

Name: FDA recall Z-0813-2013
Creator: U.S. Food and Drug Administration
Published: 2012-06-13

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-06-13, terminated 2016-08-25. It names one FDA 510(k) clearance: K073462. Product: GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.. Reason: GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2 motherboard functions intermittently. GE Healthcare has identified that these issues occur most often at sites with large Unity Network installations. It should be noted that the Dash 3000/4000/5000 patient m.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-06-13
Terminated: 2016-08-25
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K073462 — MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIESGe Medical Systems Information Technologies·cleared 2008-01-11

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, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.

Reason for recall

GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2 motherboard functions intermittently. GE Healthcare has identified that these issues occur most often at sites with large Unity Network installations. It should be noted that the Dash 3000/4000/5000 patient m

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