Recall Z-1363-2016 ยท FMZ Incubator, Neonatal
Natus Medical Incorporated
Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
| Date | Apr 11, 2016 (initiated Jan 8, 2016) |
| Status | Terminated |
| Reason | NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator. |
| Root cause | Process control |
| Action | Natus of Seattle, WA began sending the Urgent Field Safety Notice NatalCare LX Incubator letter (DOC-017939A) to consignees on 1/8/16. A repair kit to correct this issue is now available for repair of affected units. Consignees should complete the NatalCare LX Incubator Oval Port Hinge Repair Kit Order Form and FAX it 847-949-6031 or scan and email this form to Natus_Quality_Programs@natus.com. Alternately you can telephone Natus Technical Service at 888-496-2887 and order the kit from a specialist. Natus will send the kit(s) free-of-charge to the address you specify. Each upgrade will req |
| Quantity | 75 units (65 units in the US and 10 units in Pakistan) updated in final status report 36 customers with 96 units. |
| Distribution | Distribution US nationwide and Pakistan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070291 | MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX Medix I.C.S.A., Sep 21, 2007 |