Recall Z-2750-2020— GE Healthcare, LLC

Name: FDA recall Z-2750-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-22

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2020-06-22, terminated 2024-08-19. It names one FDA 510(k) clearance: K200494. Product: CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.. Reason: CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-06-22
Terminated: 2024-08-19
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K200494 — CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare·cleared 2020-03-29

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

CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.

Reason for recall

CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.

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