Reported Feb 12, 2020 · Terminated
Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958,…
Lumitex Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lumitex Inc · 8300 Dow Cir · Strongsville, OH · 44136-6600
Is this the product you have?
- 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
- Lot codes and dates
- 2014
- Production Serial NumbersAll Serial numbers beginning with QAAT; 2015
- Production Serial NumbersAll Serial numbers beginning with QAAU; 2016
- Production Serial NumbersAll Serial numbers beginning with QAAV; 2017
- Production Serial NumbersAll Serial numbers beginning with QAAW; 2018
- Production Serial NumbersSerial numbers QAAT60001 through QAAT60156
- Amount recalled
- 6837
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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