Natus Medical recalls
Natus Medical appears in 18 official U.S. recall notices indexed by RecallRadar, most recently on 2024-01-10.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 18 |
|---|---|
| Published | 2012-06-27 to 2024-01-10 |
| By agency | FDA Device (18) |
| By classification | Class II (17), Class I (1) |
| By status | terminated (15), ongoing (3) |
| Distribution named in notices | AL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NH, NJ, NY, OH, OK, PA, SC, US, VA, WA, WI |
Recalls
- External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
FDA Device · Class II · 2024-01-10 · Natus Medical
Reason: Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. - EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
FDA Device · Class II · 2024-01-10 · Natus Medical
Reason: Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. - The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to crea…
FDA Device · Class II · 2022-12-28 · Natus Medical
Reason: 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 m… - The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy an…
FDA Device · Class II · 2017-07-19 · Natus Medical
Reason: 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 fu… - Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008
FDA Device · Class II · 2017-05-10 · Natus Medical
Reason: 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… - Updated Natus neoBLUE blanket LED Phototherapy Systems
FDA Device · Class II · 2016-12-21 · Natus Medical
Reason: 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… - Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy
FDA Device · Class II · 2016-12-21 · Natus Medical
Reason: 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. - The Medix NatalCare LX Intensive Care Incubator
FDA Device · Class II · 2016-10-19 · Natus Medical
Reason: 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. - Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066
FDA Device · Class II · 2016-06-22 · Natus Medical
Reason: 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. - Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44
FDA Device · Class II · 2016-06-08 · Natus Medical
Reason: 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 chambe… - Medix NatalCare ST-LX Intensive Care Incubator
FDA Device · Class II · 2016-04-20 · Natus Medical
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 incubato… - Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066
FDA Device · Class II · 2015-10-28 · Natus Medical
Reason: 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 clear… - Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Larg…
FDA Device · Class II · 2015-04-22 · Natus Medical
Reason: 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 mel… - EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axona…
FDA Device · Class II · 2015-02-18 · Natus Medical
Reason: 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. - EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG)…
FDA Device · Class II · 2015-02-18 · Natus Medical
Reason: 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. - Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system
FDA Device · Class II · 2014-12-31 · Natus Medical
Reason: 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 orig… - The product has the Catalogue/Part number 60010
FDA Device · Class I · 2012-12-12 · Natus Medical
Reason: 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. T… - Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for…
FDA Device · Class II · 2012-06-27 · Natus Medical
Reason: 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.