Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
FDA Recall Z-1363-2016 · Posted 2016-04-11
Advertisement
Recalling FirmNatus Medical Incorporated
Recall StatusTerminated
Product CodeFMZ
Date Initiated2016-01-08
Date Terminated2017-02-10
Product Quantity75 units (65 units in the US and 10 units in Pakistan) updated in final status report 36 customers with 96 units.
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.
Firm 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 [email protected].
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: [email protected]
Root Cause
Process control
Distribution Pattern
Distribution US nationwide and Pakistan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement