CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to prov

FDA device recall Z-2266-2018 · posted 2018-06-01 · Terminated

Recall details

Recalling firm

Datex-Ohmeda, Inc.

Reason for recall

Potential for the display processor to experience an unexpected failure.

Action taken

On December 12, 2017 GE Healthcare sent letters to their consignees stating that There is a potential for the display processor to experience an unexpected failure. If this failure occurs, the device screen will temporarily go blank and will then display an Error Code EC01 XX. The blank display results in loss of monitored data being displayed to the user. There have been no injuries reported as a result of this issue. You may continue to use the system. Device performance is not affected on devices where no such display failure occurs. In the event this issue occurs, an audible alarm will sound. Mechanical ventilation will continue at previous settings. A device restart is required to clear the alarm condition. Consider using appropriate alternative means of ventilation such as a self-inflating bag or another ventilator to prevent patient injury while restarting the device. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root cause

Software change control

Status

Terminated

Product code

CBK

Quantity affected

349 (US) + 2,051 (OUS)

Distribution

Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AZ, CA, GA, ID, IL, IN, MS, NC, NJ, NK, NV, OH, OK, RI, TX, and WI., and to the countries of : Albania, Argentina, Austral

Date initiated

2017-12-08

Date posted

2018-06-01

Date terminated

2021-04-29

Location

Madison, WI

Related 510(k) clearances