Recall Z-2284-2010 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draeger Medical Systems, Inc.
Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
| Date | Aug 26, 2010 (initiated Jun 4, 2010) |
| Status | Terminated |
| Reason | Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically. |
| Root cause | Device Design |
| Action | Draeger Medical issued "Urgent-Medical Device Recall Notification" letters to affected consignees. The Delta/Gamma X XL monitor keyboards will be updated with new material at each affected facility. If the keys on affected monitors become inoperative or activate without user interaction, the customer is instructed to remove the monitor from service and contact Draeger at 978-379-8573. A Technical Service Bulletin (TSB) will be distributed globally, instructing subsidiaries to inform international customers. |
| Quantity | 800 units |
| Distribution | Worldwide Distribution - United States, including the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KS, LA, MA, ME, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, WO, and W, and the countries of United Arab Emirates, Angola, Argentina, Austria, Australia, Bos |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070566 | INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL Draeger Medical Systems, Inc., Jun 4, 2007 |