Recall Z-2573-2011 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Llc
The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's ventilatory, circulatory, and metabolic status. Mainstream monitoring uses a self-calibrating CO2 sensor to ensure continuous monitoring without interruption of connection. Reusable, lightweight (<14 gra
| Date | Jun 20, 2011 (initiated May 12, 2011) |
| Status | Terminated |
| Reason | Capnography Module, Model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. This reset clears the RAM and the module returns to default settings. |
| Root cause | Software design |
| Action | Spacelabs Medical sent a "URGENT-MEDICAL DEVICE CORRECTION" letter dated May 12, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken. Customers were recommended to set all their Capnography Module Configuration Manager alarm settings to "ON". The letter also recommended that customers brief their staff about the possibility of losing changes to the default settings and to restore them after a power interruption. A field service engineer will be contacting customers to set up a date and time when affected modules can be upgraded at no cost t |
| Quantity | 5883 units |
| Distribution | Worldwide Distribution--USA (nationwide) and countries of ALGERIA, ARGENTINA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA,COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, ISRAEL, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031124 | POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR Datex-Ohmeda, Inc., Dec 4, 2003 |