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neoBLUE blanket LED Light Box and Phototherapy Systems (2016-10-17)
- Starting date:
- October 17, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-60728
Affected Products
A. neoBLUE blanket LED Light Box
B. neoBLUE blanket LED Phototherapy Systems
Reason
Early failure of the neoBLUE Blanket System Fiberoptic Pads. These failures involved discoloration/degradation followed by eventual melting of the fiberoptic cable end that is inserted in the neoBLUE Blanket Light Box.
Affected products
A. neoBLUE blanket LED Light Box
Lot or serial number
All lots.
Model or catalog number
006254
Companies
- Manufacturer
-
Natus Medical Incorporated
5900 First Avenue South
Seattle
98108
Washington
UNITED STATES
B. neoBLUE blanket LED Phototherapy Systems
Lot or serial number
All lots.
Model or catalog number
006244
006895
Companies
- Manufacturer
-
Natus Medical Incorporated
5900 First Avenue South
Seattle
98108
Washington
UNITED STATES