Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M122...
FDA Device Recall #Z-0923-2020 — Class II — December 11, 2019
Recall Summary
| Recall Number | Z-0923-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 11, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Lumitex Inc |
| Location | Strongsville, OH |
| Product Type | Devices |
| Quantity | 6837 |
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.
Distribution Pattern
The products were distributed to the following US states: WI.
Lot / Code Information
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
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.