FDA Device recall Z-0923-2020
Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M12249…
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M12249… by Lumitex, citing 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 ex….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0923-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-11 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Lumitex |
| Distribution | WI |
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.
Identifiers
| code_info | 2014 Production Serial Numbers: All Serial numbers beginning with QAAT; 2015 Production Serial Numbers: All Serial nu…2014 Production Serial Numbers: All Serial numbers beginning with QAAT; 2015 Production Serial Numbers: All Serial numbers beginning with QAAU; 2016 Production Serial Numbers: All Serial numbers beginning with QAAV; 2017 Production Serial Numbers: All Serial numbers beginning with QAAW; 2018 Production Serial Numbers: Serial numbers QAAT60001 through QAAT60156 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0923-2020%22
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