Recall Z-2340-2018— GE Healthcare Finland Oy

Name: FDA recall Z-2340-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-25

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare Finland Oy, initiated 2018-05-25. It names 2 FDA 510(k) clearances: K131223, K102239. Product: GE Healthcare CARESCAPE Monitor B650. Reason: When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected..

Recalling firm: GE Healthcare Finland Oy
Classification: Class II
Status: Ongoing
Initiated: 2018-05-25
Firm location: Helsinki, Finland

510(k) clearances named in this recall

2 on FDA's record

K131223 — CARESCAPE MONITOR B650GE Healthcare Finland Oy·cleared 2013-08-28
K102239 — CARESCAPE MONITOR B650GE Healthcare Finland Oy·cleared 2010-10-18

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 B650

Reason for recall

When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

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