neoBLUE mini LED Phototherapy System, neoBLUE LED Therapy Device, neoBLUE Cozy, Blanket, and Compact LED Phototherapy System (2018-04-08)
- Starting date:
- April 8, 2018
- Posting date:
- May 1, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66626
Affected products
A. NEOBLUE MINI LED PHOTOTHERAPY SYSTEM
B. NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
C. NEOBLUE LED THERAPY DEVICE
D. NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
E. NEOBLUE COMPACT LED PHOTOTHERAPY SYSTEM
Reason
Natus is updating the Instructions For Use for all of the neoBLUE LED Phototherapy devices to include the information that is important to measure the intensity with a radiometer specifically designed to measure the narrow wavelength spectrum of blue LED lights. Radiometers designed to measure the broadband spectrum found in fluorescent or halogen lights may result in inaccurate intensity measurements for neoBLUE LED products.
Affected products
A. NEOBLUE MINI LED PHOTOTHERAPY SYSTEM
Lot or serial number
Not applicable
Model or catalog number
010101
Companies
- Manufacturer
-
Natus Medical Incorporated
5900 First Avenue South
Seattle
98108
Washington
UNITED STATES
B. NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
Lot or serial number
Not applicable
Model or catalog number
010121
Companies
- Manufacturer
-
Natus Medical Incorporated
5900 First Avenue South
Seattle
98108
Washington
UNITED STATES
C. NEOBLUE LED THERAPY DEVICE
Lot or serial number
Not applicable
Model or catalog number
010066
010068
010069
010070
Companies
- Manufacturer
-
Natus Medical Incorporated
5900 First Avenue South
Seattle
98108
Washington
UNITED STATES
D. NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
Lot or serial number
Not applicable
Model or catalog number
006244
006898
Companies
- Manufacturer
-
Natus Medical Incorporated
5900 First Avenue South
Seattle
98108
Washington
UNITED STATES
E. NEOBLUE COMPACT LED PHOTOTHERAPY SYSTEM
Lot or serial number
Not applicable
Model or catalog number
019001
019011
Companies
- Manufacturer
-
Natus Medical Incorporated
5900 First Avenue South
Seattle
98108
Washington
UNITED STATES