Recall Z-0923-2020— Lumitex Inc

Name: FDA recall Z-0923-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-11

Class II · Terminated

Class II FDA medical device recall by Lumitex Inc, initiated 2019-12-11, terminated 2021-09-08. It names one FDA 510(k) clearance: K120820. 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: 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..

Recalling firm: Lumitex Inc
Classification: Class II
Status: Terminated
Initiated: 2019-12-11
Terminated: 2021-09-08
Firm location: Strongsville, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K120820 — GIRAFFE BLUE SPOT PT LITELumitex, Inc.·cleared 2012-06-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.