Z-0923-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- December 11, 2019
- Termination Date
- September 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6837
Product Description
Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M1225060, M1225063, M1225064, M1225024, M1231622, M1236303, M1238489, M1238490, M1238492, M1238493, M1238495, M1238499, M1238503, M1238505, M1238507, M1238508, 2063860-001, 2063862-001, 2063870-001, 2063873-001, 2063874-001, 2071393-001, 2080916-001, 2089424-001
Reason for Recall
There is a potential for some systems built between 2014 and Jan 2018 to have a light output falling below the recommended minimum output. 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.
Distribution Pattern
The products were distributed to the following US states: WI.
Code Information
2014 Production Serial Numbers: All Serial numbers beginning with QAAT; 2015 Production Serial Numbers: All Serial numbers beginning with QAAU; 2016 Production Serial Numbers: All Serial numbers beginning with QAAV; 2017 Production Serial Numbers: All Serial numbers beginning with QAAW; 2018 Production Serial Numbers: Serial numbers QAAT60001 through QAAT60156