Terminated

GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software)

FDA Recall Z-0631-2010 · Posted 2010-01-13

Recalling FirmGeneral Electric Medical Systems Information Technology

Recall StatusTerminated

Product CodeDQA

Date Initiated2009-09-25

Date Terminated2012-05-24

Product Quantity8305

Reason for Recall

Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator's Manual may impact patient safety. When ApexPro Telemetry systems are used with SpO2 oximeters: 1. ApexPro FH Transceiver can operate with the ApexPro FH Xpod connected, but without ECG lead wires attached to the transceiver. This is unintended use of the device that is not do

Firm Action

Consignees were sent on 10/27/09 a GE Healthcare "Urgent Medical Device Correction" letter dated September 25, 2009. The letter was addressed to Risk Manger, Chief of Nursing, director of Biomedical Engineering. The letter described the Safety Issues, Affected Product Details, Product Correction, Safety Instructions and Contact Information. "ApexPro Telemetry System Operator's Manual Supplement for SpO2 was enclosed with the letter.

Root Cause

Labeling design

Distribution Pattern

Worldwide distribution: USA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUAM, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, QATAR, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, and VENEZUELA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980299APEX OXIMETERMarquette Medical Systems, Inc. · 1998-04-24

Official Source

View FDA Recall →

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