Recall Z-1382-2018 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draegar Medical Systems, Inc.
Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided
| Date | Feb 21, 2018 |
| Status | Terminated |
| Reason | The invasive pressure visual and audible alarms may not activate. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | On February 21, 2018 , Drager Medical Systems Inc. mailed an Urgent Medical Device Recall Notification to affected customers, affected customers that informs the end users of the recommended connecting sequence when using the hemodynamic pod with the M540 patient monitor. A Customer Reply Card will be included as a receipt from the customers that they received and acknowledged the recommended sequence when using the hemodynamic pod with the M540 patient monitor. To avoid encountering the identified issue, the user should follow the below identified steps whenever the hemodynamic pod is plug |
| Quantity | 28317 total products |
| Distribution | Worldwide Distribution - USA (nationwide) and the following countries:Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gre |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113798 | INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET Draeger Medical Systems, Inc., Mar 22, 2012 |