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neoBLUE LED Therapy Devices (2017-04-03)
- Starting date:
- April 3, 2017
- Posting date:
- April 21, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, Healthcare Professionals, General Public
- Identification number:
- RA-63076
Affected Products
- neoBLUE LED Therapy Device
- neoBLUE LED Therapy Device, Refurbished
Reason
Replacement of all second generation NeoBlue lights to prevent device light intensity from exceeding labeling claims.
Affected products
A. neoBLUE LED Therapy Device
Lot or serial number
All lots
Model or catalog number
- 010066
- 010068
- 010069
- 010070
Companies
- Manufacturer
-
Natus Medical Incorporated
5900 First Avenue South
Seattle
98108
Washington
UNITED STATES
B. neoBLUE LED Therapy Device, Refurbished
Lot or serial number
All lots
Model or catalog number
- 010066R
Companies
- Manufacturer
-
Natus Medical Incorporated
5900 First Avenue South
Seattle
98108
Washington
UNITED STATES