Natus Medical Incorporated
United Statesfrom the FDA registration address FDA FEI 2023988
- Devices
- 430
- Registrations
- FDA
- FDA recalls
- 193 ongoing
What Natus Medical Incorporated makes
Natus Medical Incorporated manufactures medical devices including cerebrospinal fluid shunt valves, evoked-potential audiometers, ventriculo-peritoneal/atrial shunts, audiometric ear tips, intracerebral infusion/drainage catheters, reusable electrical medical device connection cables, and infant phototherapy blanket/pad units.
The company's portfolio includes devices classified under Class I, Class II, and Class III, and is listed in the FDA UDI registry. Natus Medical Incorporated is based in the US.
Catalogue
Search and filter all 430 devicesShowing 51-100 of 430
Company details
- FDA FEI number
- 2023988
- Address
- 6225 Nancy Ridge Dr, SAN DIEGO, CA, 92121
- Website
- natus.com/
FDA recalls
FDA recall records list 19 recalls initiated by Natus Medical Incorporated, the earliest on 2009-10-01 and the most recent on 2023-11-28. By recorded status: 3 ongoing and 16 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 2
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 2
- 2024 0
- 2025 0
- 2026 0
2023
- 28 Nov 2023 Z-0634-2024 Class II Ongoing Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
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- 28 Nov 2023 Z-0635-2024 Class II Ongoing Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
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- 28 Nov 2023 Z-0634-2024 Class II Ongoing Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
2022
- 18 Nov 2022 Z-0735-2023 Class II Ongoing Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.
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- 18 Nov 2022 Z-0735-2023 Class II Ongoing Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.
2017
- 22 May 2017 Z-2701-2017 Class II Terminated Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the Olympic Pasteurmatic 3000/3500 System devices by means of disabling the devices.
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- 3 Apr 2017 Z-1924-2017 Class II Terminated The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used at a higher overall light intensity than the devices were originally cleared to deliver.
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- 22 May 2017 Z-2701-2017 Class II Terminated Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the Olympic Pasteurmatic 3000/3500 System devices by means of disabling the devices.
2016
- 28 Oct 2016 Z-0770-2017 Class II Terminated neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box.
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- 16 Sep 2016 Z-0769-2017 Class II Terminated The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability update to prevent the early failure of the fiberoptic pads experienced by some customers on older systems. These failures on previous systems involved discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.
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- 25 Aug 2016 Z-0056-2017 Class II Terminated NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate. There were several complaints of wheels bending out of alignment.
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- 22 Apr 2016 Z-1878-2016 Class II Terminated The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.
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- 11 Apr 2016 Z-2001-2016 Class II Terminated The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device.
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- 28 Oct 2016 Z-0770-2017 Class II Terminated neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box.
Show all 19 recalls
2016
- 8 Jan 2016 Z-1363-2016 Class II Terminated 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.
2015
- 5 Aug 2015 Z-0149-2016 Class II Terminated The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission.
- 16 Mar 2015 Z-1412-2015 Class II Terminated neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.
- 2 Jan 2015 Z-1067-2015 Class II Terminated Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.
- 2 Jan 2015 Z-1068-2015 Class II Terminated Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.
2014
- 19 Nov 2014 Z-0847-2015 Class II Terminated Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.
2012
- 21 May 2012 Z-1843-2012 Class II Terminated Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment.
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- 9 May 2012 Z-0447-2013 Class I Terminated The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infants. The visible clock displayed at the upper right hand corner of the screen stops advancing.
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- 21 May 2012 Z-1843-2012 Class II Terminated Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment.
2009
- 1 Oct 2009 Z-0420-2010 Unclassified (pre-2012) Terminated The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. No injuries have been reported.
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- 1 Oct 2009 Z-0420-2010 Unclassified (pre-2012) Terminated The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. No injuries have been reported.