Recall Z-2201-2013— GE Healthcare, LLC

Name: FDA recall Z-2201-2013
Creator: U.S. Food and Drug Administration
Published: 2011-07-20

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2011-07-20, terminated 2013-10-25. It names one FDA 510(k) clearance: K092027. Product: GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.. Reason: GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on th.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2011-07-20
Terminated: 2013-10-25
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K092027 — CARESCAPE MONITOR B850Ge Medical Systems Information Technologies·cleared 2009-08-28

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, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.

Reason for recall

GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on th

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