Recall Z-0631-2010 ยท DQA Oximeter
General Electric Medical Systems Information Technology
GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software)
| Date | Jan 13, 2010 (initiated Sep 25, 2009) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Labeling design |
| 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. |
| Quantity | 8305 |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980299 | APEX OXIMETER Marquette Medical Systems, Inc., Apr 24, 1998 |