Recall Z-3024-2011 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Llc
Spacelabs Medical elance Vital Signs Monitor, Model 93300. The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in all areas of a healthcare facility. It is indicated for use in adult and pediatric populations. The device facilitates the monitoring of: ECG with arrhythmia detection; respiration; non-invasive bloo
| Date | Aug 15, 2011 (initiated Sep 23, 2010) |
| Status | Terminated |
| Reason | The monitor has a 3 second delay in the waveforms and respiration alarm; the delay is not disclosed in the IFU. |
| Root cause | Error in labeling |
| Action | Spacelabs Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated September 24, 2010 to all affected customers. The letter describes the product, problem, and the action to be taken. The letter includes the revised Operator's Manual as a replacement for customers current manual. For Technical Support call Spacelabs Medical at 1-800-522-7025 and select 2. |
| Quantity | 2517 |
| Distribution | Worldwide Distribution-USA (Puerto Rico) and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093501 | ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION Spacelabs Medical, Inc., Nov 24, 2009 |