510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1968-2025Class II

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

Turncare, Inc / initiated 2023-08-10 / Open, Classified / root cause: software
FDA source (opens on fda.gov)

Turncare, Inc began a recall of Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix) on . FDA classified it as Class II and gives the reason as "A software update corrected an 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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number
Z-1968-2025
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Turncare, Inc
Product
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)
Product code
FNM Mattress, Air Flotation, Alternating Pressure
Reason for recall
A software update corrected an 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.
Root cause tag
software
FDA root cause
Software design
Action
Between November 2023 and January 2024 software updates to resolve the issue were performed by TurnCare on affected units. Successful update of the software was verified on each affected controller.
Quantity in commerce
1142 units
Distribution
US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut.
Product codes and lots
Model/Catalog Number: GS-2.5-C; Software Version: 2.5.4-69 (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, 2449.01, 2505.01, 2524.01, 2557.01, 2558.01, 2576.2.2, 2588.2.2.3, 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, 2706.2.2.3, 2737.2.2.3, 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, 2913.2.2.3, 2919.2.2.3, 2959.2.2.3, 2960.2.2.3, 2965.2.2.3, 2968.2.2.3, 2976.2.2.3, 2978.2.2.3, 3001.2.2.3, 3013.2.2.3, 3017.2.2.3, 3034.2.2.3, 3048.2.2.3, 3055.2.2.3, 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, 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4273.2.5, 4286.2.5, 4463.2.5, 4467.2.5, 4497.2.5, 4523.2.5, 4527.2.5, 4532.2.5, 4551.2.5, 4552.2.5, 4553.2.5, 4556.2.5, 4559.2.5, 4562.2.5, 4565.2.5, 4572.2.5, 4573.2.5, 4592.2.5, 4609.2.5, 4627.2.5, 4628.2.5, 4629.2.5, 4630.2.5, 4631.2.5, 4632.2.5, 4633.2.5, 4634.2.5, 4636.2.5, 4639.2.5, 4644.2.5, 4648.2.5, 4650.2.5, 4656.2.5, 4658.2.5, 4660.2.5, 4662.2.5, 4663.2.5, 4664.2.5, 4668.2.5, 4669.2.5, 4670.2.5, 4671.2.5, 4672.2.5, 4673.2.5, 4674.2.5, 4676.2.5, 4677.2.5, 4679.2.5, 4680.2.5, 4684.2.5, 4687.2.5, 4689.2.5, 4693.2.5, 4697.2.5, 4701.2.5, 4702.2.5, 4703.2.5, 4704.2.5, 4705.2.5, 4706.2.5, 4707.2.5, 4708.2.5, 4710.2.5, 4711.2.5, 4712.2.5, 4714.2.5, 4715.2.5, 4717.2.5, 4718.2.5, 4719.2.5, 4720.2.5, 4721.2.5, 4722.2.5, 4723.2.5, 4725.2.5, 4727.2.5, 4743.2.5, 4744.2.5, 4745.2.5, 4746.2.5, 4853.2.5, 4856.2.5, 4857.2.5, 4860.2.5, 4869.2.5, 4872.2.5, 4873.2.5, 4884.2.5, 4885.2.5, 4890.2.5, 4907.2.5, 4910.2.5, 5068.2.5, 5081.2.5, 2014.01, 2137.01, 2166.01, 2207.01, 2215.01, 2255.01, 2258.01, 2277.01, 2306.01, 2329.01, 2333.01, 2353.01, 2365.01, 2369.01, 2371.01, 2380.01, 2389.01, 2396.01, 2410.01, 2429.01, 2456.01, 2495.01, 2496.01, 2528.01, 2564.01, 2594.2.2.3, 2629.2.2.3, 2742.2.2, 2770.2.2.3, 2806.2.2, 2812.2.2.3, 2916.2.2, 2921.2.2.3, 2926.2.2.3, 2929.2.2.3, 2938.2.2.3, 2942.2.2.3, 2977.2.2.3, 3018.2.2.3, 3047.2.2.3, 3050.2.2.3, 3061.2.2.3, 4004.2.5, 4010.2.5, 4412.2.5, 4462.2.5, 4464.2.5, 4468.2.5, 4471.2.5, 4472.2.5, 4473.2.5, 4482.2.5, 4483.2.5, 4488.2.5, 4500.2.5, 4510.2.5, 4512.2.5, 4516.2.5, 4522.2.5, 4526.2.5, 4576.2.5, 4578.2.5, 4603.2.5, 4605.2.5, 4608.2.5, 4728.2.5, 4729.2.5, 4730.2.5, 4732.2.5, 4733.2.5, 4735.2.5, 4736.2.5, 4737.2.5, 4739.2.5, 4742.2.5, 4749.2.5, 4750.2.5, 4793.2.5, 4798.2.5, 4801.2.5, 4802.2.5, 4810.2.5, 4813.2.5, 4821.2.5, 4822.2.5, 4823.2.5, 4824.2.5, 4828.2.5, 4830.2.5, 4831.2.5, 4833.2.5, 4834.2.5, 4836.2.5, 4837.2.5, 4838.2.5, 4840.2.5, 4842.2.5, 4843.2.5, 4844.2.5, 4845.2.5, 4848.2.5, 4849.2.5, 4850.2.5, 4879.2.5, 4882.2.5, 2185.01, 2205.01, 2245.01, 2332.01, 2354.01, 2366.01, 2373.01, 2441.01, 2446.01, 2448.01, 2481.01, 2506.01, 2507.01, 2522.01, 2567.01, 2570.01, 2586.2.2.3, 2597.2.2, 2599.2.2.3, 2650.2.2, 2673.2.2, 2674.2.2, 2676.2.2, 2677.2.2.3, 2678.2.2, 2679.2.2.3, 2682.2.2, 2685.2.2, 2686.2.2, 2692.2.2, 2693.2.2, 2696.2.2, 2698.2.2, 2700.2.2.3, 2724.2.2.3, 2727.2.2.3, 2733.2.2, 2735.2.2, 2736.2.2, 2739.2.2, 2744.2.2.3, 2746.2.2.3, 2752.2.2, 2757.2.2, 2764.2.2.3, 2773.2.2, 2783.2.2, 2804.2.2.3, 2819.2.2.3, 2828.2.2.3, 2830.2.2.3, 2844.2.2.3, 2856.2.2.3, 2857.2.2.3, 2871.2.2, 2882.2.2.3, 2920.2.2, 2924.2.2.3, 2931.2.2.3, 2934.2.2.3, 2943.2.2.3, 2945.2.2.3, 2946.2.2.3, 2948.2.2.3, 2949.2.2.3, 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, 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, 2626.2.2.3, 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, 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, 4404.2.5, 4405.2.5, 4406.2.5, 4407.2.5, 4408.2.5, 4409.2.5, 4410.2.5, 4411.2.5, 4413.2.5, 4414.2.5, 4421.2.5, 4438.2.5, 4445.2.5, 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, 4645.2.5, 4646.2.5, 4647.2.5, 4666.2.5, 4667.2.5, 4678.2.5, 4681.2.5, 4685.2.5, 4716.2.5, 4726.2.5, 4731.2.5, 4738.2.5, 4741.2.5;

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1968-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1968-2025Class IIOngoingVoluntary: Firm initiated