Recall Z-0301-2007 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draeger Medical, Inc.
Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375.
| Date | Dec 19, 2006 (initiated Nov 17, 2006) |
| Status | Terminated |
| Reason | Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient. |
| Root cause | Other |
| Action | The recaling firm issued a recall letter to the US customers 11/17/2006 via certified mail. An authorized service representative will inspect each potentially affected unit. If a unit is found to have an affected docking station, the unit will be repaired or replaced free or charge. Notification to international customers will occur through the international subsidiaries. |
| Quantity | 23,345 units - 4336 US |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060039 | INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS Draeger Medical Systems, Inc., Apr 12, 2006 |