Z-1967-2025 Class II Ongoing

Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)

A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.

Model/Catalog Number: GS-2.5-C; Software Version: 2.5.4-59 (Fix); UDI-DI: (01)00860001236453; Serial Numbers: 2007.01, 2037.01, 2070.01, 2074.01, 2160.01, 2186.01, 2191.01, 2197.01, 2200.01, 2203.01, 2236.01, 2259.01, 2286.01, 2299.01, 2301.01, 2303.01, 2384.01, 2449.01, 2467.01, 2505.01, 2524.01, 2557.01, 2558.01, 2576.2.2, 2588.2.2.3, 2589.2.2.3, 2591.2.2.3, 2606.2.2.3, 2615.2.2.3, 2630.2.2.3, 2645.2.2.3, 2655.2.2.3, 2658.2.2.3, 2666.2.2, 2741.2.2.3, 2750.2.2.3, 2827.2.2.3, 2836.2.2.3, 2846.2.2.3, 2873.2.2, 2874.2.2, 2875.2.2.3, 2898.2.2, 2901.2.2.3, 2902.2.2, 2903.2.2, 2911.2.2.3, 2913.2.2.3, 2919.2.2.3, 2959.2.2.3, 2976.2.2.3, 2978.2.2.3, 3001.2.2.3, 3013.2.2.3, 3034.2.2.3, 3048.2.2.3, 3055.2.2.3, 3056.2.2.3, 2571.2.2, 2573.2.2, 2577.2.2, 2578.2.2.3, 2579.2.2, 2582.2.2.3, 2583.2.2.3, 2585.2.2, 2587.2.2, 2590.2.2, 2592.2.2, 2595.2.2, 2596.2.2, 2598.2.2, 2600.2.2, 2601.2.2, 2602.2.2.3, 2603.2.2, 2604.2.2, 2607.2.2, 2611.2.2.3, 2614.2.2, 2616.2.2, 2617.2.2.3, 2621.2.2, 2622.2.2, 2636.2.2, 2637.2.2, 2639.2.2, 2649.2.2, 2684.2.2, 2691.2.2, 2701.2.2, 2702.2.2, 2703.2.2, 2704.2.2, 2705.2.2, 2709.2.2, 2710.2.2, 2711.2.2, 2713.2.2, 2714.2.2, 2716.2.2, 2718.2.2, 2719.2.2, 2720.2.2, 2722.2.2, 2723.2.2, 2725.2.2, 2726.2.2, 2728.2.2, 2730.2.2, 2734.2.2, 2738.2.2, 2748.2.2.3, 2755.2.2, 2758.2.2, 2759.2.2, 2761.2.2, 2762.2.2, 2765.2.2, 2766.2.2, 2767.2.2, 2768.2.2, 2769.2.2, 2771.2.2, 2772.2.2, 2774.2.2, 2775.2.2, 2776.2.2, 2777.2.2.3, 2780.2.2, 2781.2.2, 2784.2.2, 2786.2.2, 2787.2.2, 2791.2.2, 2792.2.2, 2793.2.2, 2794.2.2, 2795.2.2, 2796.2.2, 2797.2.2, 2799.2.2, 2800.2.2, 2801.2.2, 2802.2.2, 2803.2.2, 2805.2.2, 2807.2.2, 2808.2.2, 2809.2.2.3, 2810.2.2, 2811.2.2, 2813.2.2, 2814.2.2, 2815.2.2, 2816.2.2, 2817.2.2, 2818.2.2.3, 2821.2.2, 2823.2.2, 2825.2.2, 2832.2.2.3, 2834.2.2, 2835.2.2, 2837.2.2, 2838.2.2, 2839.2.2, 2840.2.2, 2841.2.2, 2843.2.2, 2845.2.2, 2847.2.2, 2848.2.2, 2851.2.2, 2853.2.2, 2854.2.2, 2858.2.2, 2872.2.2, 2876.2.2.3, 2877.2.2.3, 2894.2.2, 2895.2.2.3, 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