Z-0923-2020Class II

Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961...

Name: Z-0923-2020 Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961...
Creator: Lumitex Inc
Published: 2019-12-11
License: https://open.fda.gov/license/

Lumitex Medical Devices, Inc. / initiated 2019-12-11 / Terminated / root cause: design

FDA source

Lumitex Inc began a recall of Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773... on 2019-12-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0923-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-11
Posted: 2020-01-31
Terminated: 2021-09-08
Recalling firm: Lumitex Medical Devices, Inc.
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
Product code: LBI Unit, Neonatal Phototherapy
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.
Root cause tag: design
FDA 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, 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0923-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0923-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-01-31

Product code LBI

K120820Class IIGiraffe Blue Spot Pt LiteLumitex, Inc. / cleared 2012-06-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)