GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software)
FDA device recall Z-0631-2010 · posted 2010-01-13 · Terminated
Recall details
- Recalling firm
- General Electric Medical Systems Information Technology
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 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, HO
- Date initiated
- 2009-09-25
- Date posted
- 2010-01-13
- Date terminated
- 2012-05-24
- Location
- Milwaukee, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APEX OXIMETER (K980299) | Marquette Medical Systems, Inc. | 1998-04-24 |