International Medical Devices Database

Data Source

Country

Device Classification

Parent Company

neoprene phototherapy lamp

Model / Serial
Product Description
Alert neoblue phototherapy lamp
Manufacturer
Natus
1 Event
- Recall of neoprene phototherapy lamp

RetCam ophthalmic imaging systems: the RetCam 3 model and the RetCam Shuttle model

Model / Serial
Manufacturer
Clarity Medical Systems, Inc., UNITED STATES OF AMERICA
1 Event
- Recall Or Safety Alert for RetCam ophthalmic imaging systems: the RetCam 3 model and the RetCam Shuttle model

NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM - SYSTEM WITH BLANKET

Model / Serial
Model Catalog: 006895 (Lot serial: all lots. contact manufacturer); Model Catalog: 006244 (Lot serial: all lots. contact manufacturer); Model Catalog: 006254 (Lot serial: all lots. contact manufacturer)
Product Description
neoBLUE blanket LED Phototherapy Systems;neoBLUE blanket LED Light Box
Manufacturer
NATUS MEDICAL INCORPORATED
1 Event
- Recall of NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM - SYSTEM WITH BLANKET

IMEX ELITE 100 DOPPLER

Model / Serial
Model Catalog: NW20 (Lot serial: CHN0325); Model Catalog: EN2W (Lot serial: CHN0325); Model Catalog: EN25 (Lot serial: CHN0325); Model Catalog: P300 (Lot serial: NCL1364); Model Catalog: N200 (Lot serial: CHI0346); Model Catalog: ED2WR (Lot serial: CHI0346); Model Catalog: ED2W (Lot serial: CHI0346); Model Catalog: ED23R (Lot serial: CHI0346); Model Catalog: ED23 (Lot serial: CHI0346); Model Catalog: ED20 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: NW20 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N200 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: ED2WR (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: ED2W (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: ED23R (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: ED23 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: ED20 (Lot serial: CHN0351); Model Catalog: NW20 (Lot serial: CHN0351); Model Catalog: N200 (Lot serial: CHN0351); Model Catalog: ED2WR (Lot serial: CHN0351); Model Catalog: ED2W (Lot serial: CHN0351); Mod
Product Description
2 MHz Elite OB Probes
Manufacturer
NATUS NEUROLOGY INCORPORATED
1 Event
- Recall of IMEX ELITE 100 DOPPLER

NEOBLUE LED THERAPY DEVICE

Model / Serial
Model Catalog: 010070 (Lot serial: n/a); Model Catalog: 010069 (Lot serial: n/a); Model Catalog: 010068 (Lot serial: n/a); Model Catalog: 010066 (Lot serial: n/a); Model Catalog: 010066R (Lot serial: n/a)
Product Description
neoBLUE LED Phototherapy System;neoBLUE LED Phototherapy System (refurbished)
Manufacturer
NATUS MEDICAL INCORPORATED
1 Event
- Recall of NEOBLUE LED THERAPY DEVICE

KEYPOINT SYSTEM - EP AMPLIFIER (HEADBOX)

Model / Serial
Model Catalog: 9031C077_ (Lot serial: Version 2.31 - 2.32 software)
Product Description
KEYPOINT SYSTEM - EP AMPLIFIER (HEADBOX)
Manufacturer
ALPINE BIOMED APS
1 Event
- Recall of KEYPOINT SYSTEM - EP AMPLIFIER (HEADBOX)

NATAL CARE ST-LX

Model / Serial
Model Catalog: NATAL CARE ST-LX (Lot serial: 5009); Model Catalog: NATAL CARE ST-LX (Lot serial: 5490); Model Catalog: NATAL CARE ST-LX (Lot serial: 5491)
Product Description
NATALCARE ST-LX
Manufacturer
MEDIX I.C.S.A.
1 Event
- Recall of NATAL CARE ST-LX

MINI BILI-LITE

Model / Serial
Model Catalog: (Lot serial: )
Product Description
*
Manufacturer
NATUS MEDICAL INCORPORATED
1 Event
- Recall of MINI BILI-LITE

PROTEKTOR 32 SYSTEM - ACQUISITION BOX

Model / Serial
Model Catalog: 002980 (Lot serial: 0029800164B); Model Catalog: 002980 (Lot serial: 0029800176B); Model Catalog: 002980 (Lot serial: 0029800157B); Model Catalog: 002980 (Lot serial: 002980B20292); Model Catalog: 002980 (Lot serial: 002980B20291); Model Catalog: 002980 (Lot serial: 00298000102B); Model Catalog: 002980 (Lot serial: 002980B20355); Model Catalog: 10271 (Lot serial: PRACQ0120D3-S); Model Catalog: 10271 (Lot serial: PRACQ0108C9-S); Model Catalog: 10271 (Lot serial: PRACQ0103C8-S); Model Catalog: 10271 (Lot serial: PRACQ0438E)
Product Description
PROTEKTOR 32 SYSTEM
Manufacturer
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK)
1 Event
- Recall of PROTEKTOR 32 SYSTEM - ACQUISITION BOX

EMBLETTA GOLD RECORDER

Model / Serial
Model Catalog: 2003005 (Lot serial: N/A)
Product Description
EMBLETTA GOLD - SLEEP RECORDER SYSTEM
Manufacturer
EMBLA SYSTEMS
1 Event
- Recall of EMBLETTA GOLD RECORDER

SONARA SYSTEM - BILATERAL MAIN

Model / Serial
Model Catalog: 982A0470 (Lot serial: PWH0201)
Product Description
SONARA TRANSCRANIAL DOPPLER SYSTEM
Manufacturer
NATUS NEUROLOGY INCORPORATED
1 Event
- Recall of SONARA SYSTEM - BILATERAL MAIN

NICOLET EEG - SOFTWARE

Model / Serial
Model Catalog: 828-063600 (Lot serial: 2.9.2); Model Catalog: 828-050000 (Lot serial: 2.9.2); Model Catalog: 828-062900 (Lot serial: 2.9.2); Model Catalog: 828-063500 (Lot serial: 2.9.2)
Product Description
NICOLET EEG - SOFTWARE
Manufacturer
NATUS NEUROLOGY INCORPORATED
1 Event
- Recall of NICOLET EEG - SOFTWARE

NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM - MAIN UNIT

Model / Serial
Model Catalog: 006254 (Lot serial: up to xxxx004282.); Model Catalog: 006895 (Lot serial: up to xxxx004282.); Model Catalog: 006244 (Lot serial: up to xxxx004282.)
Product Description
NeoBlue Blanket LED Phototherapy System;NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
Manufacturer
NATUS MEDICAL INCORPORATED
1 Event
- Recall of NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM - MAIN UNIT

KEYPOINT SYSTEM - KEYPOINT SOFTWARE

Model / Serial
Model Catalog: 9031S230X (Lot serial: S/N 36138); Model Catalog: 9031S230X (Lot serial: S/N 36094); Model Catalog: 9031S230X (Lot serial: S/N 36007); Model Catalog: 9031S230X (Lot serial: S/N 36011)
Product Description
Keypoint System - Keypoint Software
Manufacturer
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK)
1 Event
- Recall of KEYPOINT SYSTEM - KEYPOINT SOFTWARE

BAR ELECTRODES W/STRAP

Model / Serial
Model Catalog: 019-435600 (Lot serial: 019-435600)
Product Description
BAR ELECTRODES W/STRAP
Manufacturer
NATUS NEUROLOGY INCORPORATED
1 Event
- Recall of BAR ELECTRODES W/STRAP

NATUS QUANTUM BASE UNIT

Model / Serial
Model Catalog: 013926 (Lot serial: 013926030059); Model Catalog: 013926 (Lot serial: 013926030060); Model Catalog: 013926 (Lot serial: 013926030074); Model Catalog: 013926 (Lot serial: 013926030075)
Product Description
QUANTUM SYSTEM
Manufacturer
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK)
1 Event
- Recall of NATUS QUANTUM BASE UNIT

IMEX ELITE 100 DOPPLER

Model / Serial
Model Catalog: N500 (Lot serial: >10 contact manufacturer); Model Catalog: N300 (Lot serial: >10 contact manufacturer); Model Catalog: NW20 (Lot serial: >10 contact manufacturer)
Product Description
IMEX ELITE 100 DOPPLER;IMEX ELITE 200 DOPPLER
Manufacturer
NATUS NEUROLOGY INCORPORATED
1 Event
- Recall of IMEX ELITE 100 DOPPLER

HEPA FILTER 100105-01

Model / Serial
Model Catalog: (Lot serial: N/A)
Product Description
HEPA FILTER 100105-01
Manufacturer
NATUS MEDICAL INCORPORATED
1 Event
- Recall of HEPA FILTER 100105-01

RETCAM SHUTTLE

Model / Serial
Model Catalog: 20-000100 (Lot serial: n/a); Model Catalog: RETCAM 3 (Lot serial: n/a)
Product Description
RETCAM SHUTTLE
Manufacturer
CLARITY MEDICAL SYSTEMS INC.
1 Event
- Recall of RETCAM SHUTTLE

WATER CALORIC IRRIGATOR

Model / Serial
Model Catalog: AQUASTAR (Lot serial: 1GV 17548 05); Model Catalog: AQUASTAR (Lot serial: 1GV 17548 04)
Product Description
wATER CALORIC IRRIGATOR
Manufacturer
GENIE AUDIO INC.
1 Event
- Recall of WATER CALORIC IRRIGATOR

NATAL CARE ST-LX

Model / Serial
Model Catalog: NATAL CARE ST-LX (Lot serial: 5491); Model Catalog: NATAL CARE ST-LX (Lot serial: 5490)
Product Description
NATALCARE ST-LX
Manufacturer
MEDIX I.C.S.A.
1 Event
- Recall of NATAL CARE ST-LX

Alpine Microtargeting Electrode Cable

Model / Serial
9013C0505 | 36299
Product Description
MD: Electroencephalograph cable/lead
Manufacturer
Alpine Biomed ApS
1 Event
- Field Safety Notices about Alpine Microtargeting Electrode Cable

RetCam

Model / Serial
3, Shuttle, Portable | 6.0, 6.1, 6.2
Product Description
MD: Patient health record information system application software
Manufacturer
Clarity Medical Systems, Inc.
1 Event
- Field Safety Notices about RetCam

Echo-Screen / AccuScreen

Model / Serial
Product Description
MD: Audiometric evoked-potential unit
Manufacturer
Natus Europe GmbH
1 Event
- Field Safety Notices about Echo-Screen / AccuScreen

Keypoint.NET

Model / Serial
2.2
Product Description
MD: Electromyograph
Manufacturer
Alpine Biomed ApS
1 Event
- Field Safety Notices about Keypoint.NET

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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