Recall Z-0923-2020 ยท LBI Unit, Neonatal Phototherapy
Lumitex Inc
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-
| Date | Dec 11, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Correction notification letter was sent to the customer. Actions to be taken by the Customer/User: Please notify all end users, that have received the above listed product that to ensure the patient gets proper levels of treatment they should take the following actions. 1. Immediately check all your device outputs using a BiliBlanket Meter II bilimeter and continue to do so prior to every use, as listed in the Instructions for Use as well as during the treatment session. Instructions as to how to measure your devices output are provided in both the Operation, Maintena |
| Quantity | 6837 |
| Distribution | The products were distributed to the following US states: WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120820 | GIRAFFE BLUE SPOT PT LITE Lumitex, Inc., Jun 8, 2012 |