BiliLux (2019-08-21)
- Starting date:
- August 21, 2019
- Posting date:
- January 10, 2020
- 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-72065
Last updated: 2020-01-10
Affected Products
BiliLux
Reason
Total irradiance of the phototherapy light of the BiliLux is exceeding the total irradiance limits published in the product IFU. The led light intensity from the supplier has increased over time since the initial production of the BiliLux in 2017. Current design of the BiliLux does not allow the manufacturer to maintain the total irradiance within the published range.
Affected products
BiliLux
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MU20100
Companies
- Manufacturer
-
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
Pennsylvania
UNITED STATES