# FDA recall Z-0923-2020

> **Lumitex Inc** · Class II · device recall initiated 2019-12-11.

## 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.

## Distribution

The products were distributed to the following US states: WI.

## Key facts

- **Recall number:** Z-0923-2020
- **Recalling firm:** Lumitex Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-11
- **Report date:** 2020-02-12
- **Termination date:** 2021-09-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Strongsville, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0923-2020

## Citation

> AI Analytics. FDA recall Z-0923-2020. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0923-2020. Source: US FDA. Licensed CC0.

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