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NeoBlue Blanket LED Phototherapy System (2016-12-02)
- Starting date:
- December 2, 2016
- Posting date:
- December 16, 2016
- 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-61478
Affected Products
- NeoBlue Blanket LED Phototherapy System
- NeoBlue Blanket LED Phototherapy System
Reason
Premature failure of device involving discoloration/degradation followed by eventual melting of the fiber optic cable end.
Affected products
A. NeoBlue Blanket LED Phototherapy System
Lot or serial number
up to xxxx004282.
Model or catalog number
- 006254
Companies
- Manufacturer
-
Natus Medical Incorporated
5900 First Avenue South
Seattle
98108
Washington
UNITED STATES
B. NeoBlue Blanket LED Phototherapy System
Model or catalog number
- 006244
- 006895
Companies
- Manufacturer
-
Natus Medical Incorporated
5900 First Avenue South
Seattle
98108
Washington
UNITED STATES