Recall Z-3048-2011 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draeger Medical Systems, Inc.
Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
| Date | Aug 22, 2011 (initiated Jul 29, 2011) |
| Status | Terminated |
| Reason | Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically. |
| Root cause | Device Design |
| Action | Draeger Medical sent an "Urgent Medical Device Recall Notification" letters dated July 2011 to all affected customers. The letter included product and problem affected. The letter informed the customer a Draeger representative will contact them to upgrade the system. Until the solution is implemented, Draeger recommends the Delta and/or Gamma XXL may be used. If the affected monitors become inoperative or activate without user interaction, Draeger advises removing the monitor from service and contacting a Draeger representative. For questions or for information on this recall please cal |
| Quantity | 29 |
| Distribution | Worldwide Distribution - (USA) Nationwide distribution including the states of AK, FL, LA, MN, MS, MO, NJ, NC, OH, OK, PA, TN, TX, NC, NH, NJ, NY, WV, and WI; and the countries of Australia, Austria, Argentina, Bahrain, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Geor |
| 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 |