Lumitex recalls specific models of Giraffe Blue Spot PT Lite phototherapy systems built between 2014-2018 due to potential light output falling below safe levels from heat exposure.
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.
Lumitex is recalling certain Giraffe Blue Spot PT Lite phototherapy systems made between 2014 and early 2018. These systems may produce insufficient light output when exposed to high temperatures, which could affect treatment effectiveness.
The system's light output can drop below safe levels when the internal light pipe gets too hot. This happens during normal use if the device is exposed to elevated temperatures, which is against the manufacturer's operating guidelines.
Parents using the phototherapy system for newborns are most at risk. The affected units were sold between 2014 and January 2018 with specific serial number patterns.
Check for model numbers M1224917, M1231533, M1225025, M1224961, M1224958, or other listed serial numbers. Units made in 2014-2018 with specific serial prefixes (QAAT for 2014, QAAU for 2015, etc.) are affected.
Look for model numbers M1224917, M1231533, M1225025, M1224961, M1224958, or other listed serial numbers on the device.
Confirm the production year by checking the serial number prefix: QAAT for 2014, QAAU for 2015, QAAV for 2016, QAAW for 2017, or QAAT60001-QAAT60156 for 2018.
The system may produce insufficient light output when the internal light pipe gets too hot, which is against the manufacturer's operating guidelines.
Check the model numbers and production year as described in the recall notice to determine if your unit is affected.
Look for model numbers M1224917, M1231533, M1225025, M1224961, M1224958, or other listed serial numbers. Units made in 2014-2018 with specific serial prefixes (QAAT for 2014, QAAU for 2015, etc.) are affected.
We’ve drafted a message you can send Lumitex to request your refund or repair — edit it as you like.
Subject: Recall Z-0923-2020 — Lumitex Lumitex Hello, I own a Lumitex that is covered by recall Z-0923-2020 from Lumitex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
