Giraffe Blue Spot PT Lite Phototherapy Systems (2019-12-23)
- Starting date:
- December 23, 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-72079
Last updated: 2020-01-10
Affected Products
Giraffe Blue Spot PT Lite Phototherapy Systems
Reason
Some Giraffe Blue Spot PT Lite Phototherapy Systems built between 2014 and Jan 2018, have a light output falling below the recommended minimum output for the Giraffe Blue Spot PT. This problem has been associated with exposure of the light pipe to elevated temperatures, which is contra-indicated in the operation, maintenance, and service manual. There have not been any reported harms or adverse events associated with the Giraffe Blue Spot PT Lite.
Affected products
Giraffe Blue Spot PT Lite Phototherapy Systems
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- M1236303
- M1238508
Companies
- Manufacturer
-
Datex-Ohmeda, Inc
9900 Innovation Drive
Wauwatosa
53226
Wisconsin
UNITED STATES