Giraffe Blue Spot PT LiteTM Phototherapy System — Class II medical device recall Z-0923-2020
Terminated recall by Lumitex Inc, reported 2020-02-12, distributed in WI. There is a potential for some systems built between 2014 and Jan 2018 to have a light output falling below the
| Recall number | Z-0923-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lumitex Inc, Strongsville, OH, United States |
| Recall initiated | 2019-12-11 |
| Classified | 2020-01-31 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2021-09-08 |
| Distributed | WI |
| Quantity | 6,837 |
| Serial numbers | QAAT60001 |
| Model numbers | 2063860-001, 2063862-001, 2063870-001, 2063873-001, 2063874-001, 2071393-001, 2080916-001, 2089424-001, M1224917, M1224957, M1224958, M1224959, M1224960, M1224961, M1224963, M1225023, M1225024, M1225025, M1225059, M1225060, M1225063, M1225064, M1225066, M1225773, M1231533 and 12 more |
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, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0923-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.