BEUDAMED
    FDA Enforcement Class II Ongoing

    GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-01048740; 7) M1112198-01052386; 8) M1112198-01054697; 9) M1112198-01068942; 10) M1112198-01084972; 11) M1112198-01090848; 12) M1112198-01093457; 13) M1112198-01117766; 14) M1112198-01139893; 15) M1112198-01156745; 16) M1112198-01167230; 17) M1112198-01177090; 18) M1112198-01183599; 19) M1112198-01185372; 20) M1112198-01193801; 21) M1112198-01200764; 22) M1112198-01245548; 23) M1112198-01253742; 24) M1112198-01274059. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    Recall: Z-3081-2024 · Reported October 2, 2024

    Enforcement

    Recall Number
    Z-3081-2024
    Event ID
    95216
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wipro GE Healthcare Private Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2024
    Initiation Date
    August 9, 2024
    Classification Date
    September 20, 2024
    Address
    122 Part 1, Odyssey And Galileo, Bengaluru, N/A, India

    Description

    GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-01048740; 7) M1112198-01052386; 8) M1112198-01054697; 9) M1112198-01068942; 10) M1112198-01084972; 11) M1112198-01090848; 12) M1112198-01093457; 13) M1112198-01117766; 14) M1112198-01139893; 15) M1112198-01156745; 16) M1112198-01167230; 17) M1112198-01177090; 18) M1112198-01183599; 19) M1112198-01185372; 20) M1112198-01193801; 21) M1112198-01200764; 22) M1112198-01245548; 23) M1112198-01253742; 24) M1112198-01274059. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    Reason

    GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.

    Code Info

    1) M1112198-01045518, UDI/DI 00840682152709, Serial Numbers: PBW23420278SA, PBW23390175SA, PBW24241071SA, PBW24241072SA, PBW24241075SA, PBW23340090SA; 2) M1112198-01045579, UDI/DI 00840682152709, Serial Numbers: PBW24241078SA, PBW24241079SA, PBW24241063SA, PBW24241076SA; 3) M1112198-01047148, UDI/DI 00840682152709, Serial Numbers: PBW24241068SA, PBW24241070SA, PBW24241065SA, PBW24241064SA, PBW24241066SA, PBW24241067SA, PBW24241069SA; 4) M1112198-01047271, UDI/DI 00840682152716, Serial Numbers: PBW23492144SA, PBW23482075SA, PBW23492149SA, PBW24062087SA, PBW24062078SA, PBW24062081SA, PBW23492145SA, PBW24152231SA, PBW24152225SA, PBW24152229SA, PBW23482085SA, PBW24202294SA, PBW24202292SA, PBW24202293SA, PBW24212323SA, PBW24212324SA, PBW24152226SA, PBW24152227SA, PBW24052060SA, PBW23492142SA; 5) M1112198-01048731, UDI/DI 00840682152709, Serial Numbers: PBW24241087SA, PBW24241086SA, PBW24241085SA, PBW23320042SA, PBW23320041SA, PBW24241084SA, PBW23320035SA; 6) M1112198-01048740, UDI/DI 00840682152716, Serial Numbers: PBW23482093SA; 7) M1112198-01052386, UDI/DI 00840682152716, Serial Numbers: PBW23482100SA, PBW24202309SA, PBW24202313SA, PBW24202310SA, PBW24202315SA, PBW24202312SA, PBW24202314SA, PBW24202311SA; 8) M1112198-01054697, UDI/DI 00840682152716, Serial Numbers: PBW24132200SA; 9) M1112198-01068942, UDI/DI 00840682152716, Serial Numbers: PBW23472056SA, PBW24062069SA, PBW24112144SA, PBW24062072SA, PBW24112157SA, PBW24112149SA, PBW24112145SA, PBW24112158SA, PBW24112148SA, PBW24112147SA, PBW24112155SA, PBW24112150SA, PBW24112153SA, PBW24112156SA, PBW24112152SA, PBW24112154SA, PBW24112146SA, PBW24112151SA, PBW24142209SA; 10) M1112198-01084972, UDI/DI 00840682152716, Serial Numbers: PBW23462025SA, PBW23462038SA, PBW23462039SA, PBW23472051SA, PBW23472049SA, PBW23472050SA, PBW24132204SA, PBW24132203SA, PBW24132205SA, PBW24122189SA, PBW24122190SA; 11) M1112198-01090848, UDI/DI 00840682152716, Serial Numbers: PBW24122198SA, PBW24122195SA, PBW24122197SA; 12) M1112198-01093457, UDI/DI 00840682152716, Serial Numbers: PBW24202308SA, PBW24132201SA; 13) M1112198-01117766, UDI/DI 00840682152709, Serial Numbers: PBW24110390SA; 14) M1112198-01139893, UDI/DI 00840682152716, Serial Numbers: PBW23242002SA, PBW23242003SA, PBW23242000SA, PBW23242001SA, PBW23512155SA, PBW24062070SA, PBW24172255SA, PBW24172253SA, PBW24172254SA, PBW24172251SA, PBW24172250SA, PBW24212327SA, PBW24212328SA; 15) M1112198-01156745, UDI/DI 00840682152716, Serial Numbers: PBW24192258SA; 16) M1112198-01167230, UDI/DI 00840682152716, Serial Numbers: PBW23462035SA, PBW23462036SA, PBW23462040SA, PBW24112159SA; 17) M1112198-01177090, UDI/DI 00840682152716, Serial Numbers: PBW23482099SA; 18) M1112198-01183599, UDI/DI 00840682152716, Serial Numbers: PBW23492140SA, PBW23482090SA, PBW23482092SA, PBW23482089SA, PBW23482086SA, PBW23492139SA, PBW23482087SA, PBW23482088SA, PBW23482091SA, PBW23482103SA, PBW23482104SA, PBW23482105SA; 19) M1112198-01185372, UDI/DI 00840682152716, Serial Numbers: PBW23482079SA, PBW23482081SA, PBW23482082SA, PBW23482083SA, PBW23482078SA; 20) M1112198-01193801, UDI/DI 00840682152716, Serial Numbers: PBW23502154SA, PBW24172252SA; 21) M1112198-01200764, UDI/DI 00840682152716, Serial Numbers: PBW23472043SA; 22) M1112198-01245548, UDI/DI 00840682152716, Serial Numbers: PBW24062101SA; 23) M1112198-01253742, UDI/DI 00840682152716, Serial Numbers: PBW24052062SA, PBW24052063SA, PBW24052066SA, PBW24052065SA, PBW24052064SA; 24) M1112198-01274059, UDI/DI 00840682152716, Serial Numbers: PBW24192278SA, PBW24192279SA.

    Distribution

    US and Australia, Denmark, France, Germany, Ireland, ITALY, New Zealand, Poland, Portugal, Slovenia, Spain, SWITZERLAND, United Arab Emirates, United Kingdom.

    Quantity

    137 units