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Terminated

GE Carestation 30 anesthesia systems

FDA Recall Z-2955-2018 · Posted None

Recalling FirmGE Medical Systems China Co., Ltd.
Recall StatusTerminated
Product CodeBSZ
Date Initiated2018-07-24
Date Terminated2020-12-16
Product Quantity252 units

Reason for Recall

On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia.

Firm Action

The firm issued a medical device correction notice on 07/24/2018. The notice explained the issue and provided safety instructions should the use observe a switch change. The units will be corrected. Questions or concerns may contact 1-800-437-1171 or the local service representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K151570Carestation 620/650/650CDatex-Ohmeda, Inc. · 2016-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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