FDA Medical Device Recalls (openFDA)
Natus Medical Incorporated: Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
- Recall number
- Z-1363-2016
- Recalling firm
- Natus Medical Incorporated
- Product
- Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
- Status
- Terminated
- Initiated
- 2016-01-08
- Posted
- 2016-04-11
- Terminated
- 2017-02-10
- 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 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K070291"]
- PMA numbers
- not on file
- Product code
- FMZ
- Firm FEI
- 3018859
- Firm city
- Seattle
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28