Health product recall

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