Z-1363-2016Class II

Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator

Name: Z-1363-2016 Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator
Creator: Natus Medical Incorporated
Published: 2016-01-08
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2016-01-08 / Terminated / root cause: manufacturing process

FDA source

Natus Medical Incorporated began a recall of Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator on 2016-01-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1363-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-08
Posted: 2016-04-11
Terminated: 2017-02-10
Recalling firm: Natus Medical Incorporated
Product: Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
Product code: FMZ Incubator, Neonatal
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.
Root cause tag: manufacturing process
FDA 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 [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]
Quantity in commerce: 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.
Product codes and lots: Serial numbers: 5337; 5336; 5335; 5334; 5333; 5332; 5331; 5330; 5329; 5328; 5327; 5326; 5325; 5324; 5323; 5294; 5293; 5292; 5291; 5290; 5289; 5287; 5283; 5282; 5281; 5280; 5278; 5277; 5276; 5257; 5256; 5255; 5254; 5253; 5252; 5251; 5250; 5249; 5248; 5228; 5227; 5226; 5225; 5224; 5223; 5222; 5221; 5220; 5219; 5214; 5213; 5212; 5211; 5210; 5209; 5139; 5138; 5136; 5135; 5134; 5133; 5132; 5131; 5130; 5129; 5097; 5096; 5057; 5056; 5053; 5051; 5048; 5047; 5046; 5045. Serial numbers were updated in the final status report. They are as follows: 5552; 5551; 5550; 5549; 5510; 5509; 5508;5507; 5506; 5505; 5504; 5389; 5388; 5385; 5383; 5337; 5336; 5335; 5334; 5333; 5332; 5331; 5330; 5329; 5328; 5327; 5326; 5325; 5324; 5323; 5322; 5294; 5293; 5292; 5291; 5290; 5289; 5288; 5287; 5286; 5285; 5284; 5283; 5282; 5281; 5280; 5279; 5278; 5277; 5276; 5257; 5256; 5255; 5254; 5253; 5252; 5251; 5250; 5249; 5248; 5228; 5227; 5226; 5225; 5224; 5223; 5222; 5221; 5220; 5219; 5214; 5213; 5212; 5211; 5210; 5209; 5139; 5138; 5136; 5135; 5134; 5133; 5132; 5131; 5130; and 5129. The following serial numbers were removed: 5097; 5096; 5057; 5056; 5053; 5051; 5048; 5047; 5046; and 5045.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1363-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1363-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-11

Product code FMZ

K070291Class IIMedix Natal Care Intensive Care Incubator, Models-Natal Care St-Mx/lx/bxMedix I.C.S.A. / cleared 2007-09-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)