Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Vers

Summary

The FDA issued a Class II for Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model by Turncare, Inc. Reason: 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.

Details

Product Description

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)

Lot/Code Info: 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, 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2943.2.2.3, 2945.2.2.3, 2946.2.2.3, 2948.2.2.3, 2971.2.2.3, 2984.2.2.3, 2989.2.2.3, 2990.2.2.3, 2994.2.2.3, 3006.2.2.3, 3010.2.2.3, 3016.2.2.3, 3019.2.2.3, 3022.2.2.3, 3024.2.2.3, 3025.2.2.3, 3028.2.2.3, 3037.2.2.3, 3038.2.2.3, 3039.2.2.3, 3043.2.2.3, 3044.2.2.3, 3045.2.2.3, 3046.2.2.3, 3054.2.2.3, 3059.2.2.3, 2572.2.2, 2574.2.2.3, 2605.2.2, 2608.2.2, 2609.2.2, 2612.2.2, 2618.2.2, 2619.2.2, 2623.2.2.3, 2624.2.2, 2627.2.2, 2628.2.2, 2986.2.2.3, 3004.2.2.3, 4018.2.5, 4038.2.5, 4042.2.5, 4321.2.5, 4356.2.5, 4357.2.5, 4362.2.5, 4382.2.5, 4386.2.5, 4403.2.5, 4426.2.5, 4449.2.5, 4451.2.5, 4452.2.5, 4453.2.5, 4456.2.5, 4458.2.5, 4459.2.5, 4461.2.5, 4498.2.5, 4504.2.5, 4216.2.5, 4371.2.5, 4376.2.5, 4377.2.5, 4388.2.5, 4389.2.5, 4391.2.5, 4393.2.5, 4397.2.5, 4400.2.5, 4404.2.5, 4405.2.5, 4406.2.5, 4407.2.5, 4408.2.5, 4409.2.5, 4410.2.5, 4411.2.5, 4414.2.5, 4421.2.5, 4438.2.5, 4446.2.5, 4455.2.5, 4457.2.5, 4056.2.5, 4489.2.5, 4637.2.5, 4638.2.5, 4640.2.5, 4642.2.5, 4643.2.5, 4645.2.5, 4646.2.5, 4666.2.5, 4667.2.5, 4678.2.5, 4681.2.5, 4683.2.5, 4692.2.5, 4700.2.5, 4716.2.5, 4726.2.5, 4731.2.5, 4741.2.5;

Quantity Affected: 1081 units

Reason for Recall

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-11-01

Company