Lumitex Giraffe Blue Spot PT Lite Phototherapy Systems Recalled for Low Light Output
Lumitex is recalling Giraffe Blue Spot PT Lite Phototherapy Systems because some units may have light output below the recommended minimum.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the product may not function as intended (low light output), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Lumitex Inc is recalling 6,837 units of the Giraffe Blue Spot PT Lite Phototherapy System. The recall affects specific model numbers and serial numbers produced between 2014 and January 2018. The affected products were distributed to the state of Wisconsin.
The recall is due to a potential issue where the light output of some systems may fall below the recommended minimum. This problem is associated with exposure of the light pipe to elevated temperatures, which is contra-indicated in the Operation, Maintenance, and Service Manual.
Consumers should stop using the affected phototherapy systems and contact Lumitex Inc for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Lumitex Inc
- Hazard
- Affected units
- 6,837
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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
Distribution
Distributed in 1 state:
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