Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
FDA device recall Z-1363-2016 · posted 2016-04-11 · Terminated
Recall details
- Recalling firm
- Natus Medical Incorporated
- Reason for recall
- 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.
- Action taken
- 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 require up to - 1 hour of time and require simple hand tools. If you have any questions, please contact Technical Service at 888-496-2887 or send email to: customer.service@natus.com
- Root cause
- Process control
- Status
- Terminated
- Product code
- FMZ
- Quantity affected
- 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.
- Date initiated
- 2016-01-08
- Date posted
- 2016-04-11
- Date terminated
- 2017-02-10
- Location
- Seattle, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX (K070291) | Medix I.C.S.A. | 2007-09-21 |