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NEOBLUE BLANKET LED PHOTOTHERAPY (2015-03-16)
- Starting date:
- March 16, 2015
- Posting date:
- April 2, 2015
- 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-52775
Recalled Products
- NEOBLUE BLANKET LED PHOTOTHERAPY WITH LARGE BLANKET/PAD
- NEOBLUE BALNKET LED PHOTOTHERAPY SYSTEM
Reason
Technical bulletin: potential early failure of neoBLUE blanket system fiber optic pads. Customers are asked to inspect pads before use for discolouration or degradation followed by eventual melting of the fiber optic bundle at the connector that is inserted in the light box. The failure occurs because of heat buildup at the fiber optic connector inside the neoBlue blanket light box. Contact your distributor, if there is visible discolouration or fiber optic bundle surface feels rough and uneven. Maintaining the system at factory settings and turn off whenever not in use will reduce the degradation process.
Affected products
A. NEOBLUE BLANKET LED PHOTOTHERAPY WITH LARGE BLANKET/PAD
Lot or serial number
Not applicable
Model or catalog number
- 006254
Companies
- Manufacturer
-
Natus Medical Incorporated,
5900 First Avenue South,
Seattle
98108
Washington
UNITED STATES
B. NEOBLUE BALNKET LED PHOTOTHERAPY SYSTEM
Lot or serial number
Not applicable
Model or catalog number
- 006244
- 006895
Companies
- Manufacturer
-
Natus Medical Incorporated,
5900 First Avenue South,
Seattle
98108
Washington
UNITED STATES