Strongsville, OH, United States
Lumitex Inc recalls
1 recall recorded since 2018, most recently on 11 December 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 December 2019
- Terminated
- 8 September 2021
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0923-2020
- Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M1225060, M1225063, M122506
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.