Class 2 Device Recall Giraffe Blue Spot PT LiteTM Phototherapy System

• Date Initiated by Firm: December 11, 2019
• Create Date: January 31, 2020
• Recall Status: Terminated on September 08, 2021
• Recall Number: Z-0923-2020
• Recall Event ID: 84562
• 510(K)Number: K120820
• Product Classification: Unit, neonatal phototherapy - Product Code LBI
• 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
• 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
• Recalling Firm/ Manufacturer: Lumitex Inc; 8300 Dow Cir; Strongsville OH 44136-6600
• For Additional Information Contact: 440-243-8401
• Manufacturer 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.
• FDA Determined 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, Maintenance, and Service Manual Section 2.1 Pre-Use Checkout Procedure and in the Quick Reference Guide attached to every unit and are detailed below in Appendix 1. Take out of service any units found to have irradiance levels less than 27W/cm2/nm and await the free kit to correct the unit that GE Healthcare will be sending for all potentially affected units. Elevated heat can cause the light pipe optical fiber to protrude through its reflector aperture, creating an unfocused spot with less than 27W/cm2/nm output as described above. The photos below show the effect and can be used in conjunction with the BiliBlanket Meter II bilimeter to identify units with a low light condition due to elevated heat exposure. 2. As previously stated, exposing the shade head to elevated heat from the warmer is contra-indicated with this device. To prevent potential damage to light pipes due to elevated heat, we remind that care should be taken to position the light pipe, as shown in the Instructions for Use Section 2.2 Operation and in the Quick Reference Guide, keeping the light pipe Shade head outside the direct path of warmers. Product Correction: To correct any existing devices experiencing low light output due to fiber protrusion and to prevent potential future low light output due to fiber protrusion, GE Healthcare will send a kit to fix all potentially affected units free of c
• Quantity in Commerce: 6837
• Distribution: The products were distributed to the following US states: WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LBI