| | Class 2 Device Recall Guardian 2 System |  |
| Date Initiated by Firm | August 10, 2023 |
|---|
| Date Posted | June 12, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1968-2025 |
|---|
| Recall Event ID |
96874 |
| Product Classification |
Mattress, air flotation, alternating pressure - Product Code FNM
|
| 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) |
|---|
| Code Information |
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, 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, 2712.2.2, 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, 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, 2802.2.2.3, 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, 2848.2.2.3, 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, 2897.2.2, 2900.2.2.3, 2904.2.2, 2906.2.2, 2907.2.2, 2908.2.2, 2909.2.2, 2966.2.2.3, 3000.2.2.3, 3007.2.2.3, 3023.2.2.3, 4017.2.5, 4019.2.5, 4022.2.5, 4023.2.5, 4025.2.5, 4027.2.5, 4032.2.5, 4034.2.5, 4035.2.5, 4037.2.5, 4041.2.5, 4043.2.5, 4044.2.5, 4045.2.5, 4047.2.5, 4049.2.5, 4050.2.5, 4051.2.5, 4052.2.5, 4053.2.5, 4054.2.5, 4055.2.5, 4057.2.5, 4058.2.5, 4059.2.5, 4061.2.5, 4062.2.5, 4063.2.5, 4064.2.5, 4065.2.5, 4066.2.5, 4067.2.5, 4069.2.5, 4070.2.5, 4071.2.5, 4072.2.5, 4073.2.5, 4074.2.5, 4075.2.5, 4076.2.5, 4077.2.5, 4078.2.5, 4079.2.5, 4080.2.5, 4081.2.5, 4082.2.5, 4083.2.5, 4085.2.5, 4086.2.5, 4087.2.5, 4088.2.5, 4089.2.5, 4090.2.5, 4091.2.5, 4092.2.5, 4093.2.5, 4094.2.5, 4095.2.5, 4096.2.5, 4097.2.5, 4098.2.5, 4099.2.5, 4100.2.5, 4101.2.5, 4102.2.5, 4103.2.5, 4104.2.5, 4105.2.5, 4106.2.5, 4107.2.5, 4108.2.5, 4109.2.5, 4110.2.5, 4111.2.5, 4112.2.5, 4113.2.5, 4114.2.5, 4115.2.5, 4117.2.5, 4118.2.5, 4120.2.5, 4121.2.5, 4122.2.5, 4123.2.5, 4124.2.5, 4125.2.5, 4126.2.5, 4127.2.5, 4128.2.5, 4129.2.5, 4130.2.5, 4132.2.5, 4133.2.5, 4134.2.5, 4136.2.5, 4139.2.5, 4140.2.5, 4173.2.5, 4178.2.5, 4179.2.5, 4180.2.5, 4181.2.5, 4182.2.5, 4183.2.5, 4184.2.5, 4185.2.5, 4186.2.5, 4187.2.5, 4189.2.5, 4190.2.5, 4191.2.5, 4192.2.5, 4193.2.5, 4194.2.5, 4195.2.5, 4196.2.5, 4197.2.5, 4198.2.5, 4199.2.5, 4201.2.5, 4202.2.5, 4203.2.5, 4204.2.5, 4205.2.5, 4206.2.5, 4207.2.5, 4208.2.5, 4209.2.5, 4211.2.5, 4212.2.5, 4214.2.5, 4215.2.5, 4217.2.5, 4219.2.5, 4220.2.5, 4221.2.5, 4222.2.5, 4228.2.5, 4229.2.5, 4230.2.5, 4231.2.5, 4232.2.5, 4233.2.5, 4234.2.5, 4235.2.5, 4236.2.5, 4237.2.5, 4238.2.5, 4239.2.5, 4240.2.5, 4241.2.5, 4242.2.5, 4245.2.5, 4246.2.5, 4247.2.5, 4248.2.5, 4249.2.5, 4250.2.5, 4252.2.5, 4254.2.5, 4255.2.5, 4256.2.5, 4258.2.5, 4259.2.5, 4260.2.5, 4261.2.5, 4262.2.5, 4263.2.5, 4270.2.5, 4277.2.5, 4278.2.5, 4279.2.5, 4280.2.5, 4281.2.5, 4282.2.5, 4284.2.5, 4285.2.5, 4287.2.5, 4289.2.5, 4294.2.5, 4304.2.5, 4306.2.5, 4310.2.5, 4311.2.5, 4314.2.5, 4315.2.5, 4317.2.5, 4318.2.5, 4319.2.5, 4320.2.5, 4322.2.5, 4323.2.5, 4324.2.5, 4325.2.5, 4326.2.5, 4327.2.5, 4328.2.5, 4330.2.5, 4331.2.5, 4333.2.5, 4334.2.5, 4336.2.5, 4337.2.5, 4338.2.5, 4340.2.5, 4341.2.5, 4342.2.5, 4345.2.5, 4347.2.5, 4348.2.5, 4349.2.5, 4351.2.5, 4355.2.5, 4358.2.5, 4359.2.5, 4361.2.5, 4364.2.5, 4366.2.5, 4368.2.5, 4370.2.5, 4372.2.5, 4373.2.5, 4375.2.5, 4424.2.5, 4427.2.5, 4428.2.5, 4429.2.5, 4431.2.5, 4434.2.5, 4435.2.5, 4436.2.5, 4437.2.5, 4439.2.5, 4443.2.5, 4478.2.5, 4479.2.5, 4481.2.5, 4484.2.5, 4487.2.5, 4490.2.5, 4492.2.5, 4493.2.5, 4494.2.5, 4514.2.5, 4519.2.5, 4528.2.5, 4530.2.5, 4531.2.5, 4533.2.5, 4534.2.5, 4535.2.5, 4536.2.5, 4537.2.5, 4538.2.5, 4539.2.5, 4540.2.5, 4541.2.5, 4542.2.5, 4543.2.5, 4544.2.5, 4545.2.5, 4546.2.5, 4547.2.5, 4548.2.5, 4549.2.5, 4550.2.5, 4554.2.5, 4555.2.5, 4558.2.5, 4560.2.5, 4561.2.5, 4563.2.5, 4564.2.5, 4566.2.5, 4567.2.5, 4570.2.5, 4571.2.5, 4574.2.5, 4575.2.5, 4597.2.5, 4598.2.5, 4599.2.5, 4610.2.5, 4612.2.5, 4613.2.5, 4614.2.5, 4615.2.5, 4616.2.5, 4617.2.5, 4618.2.5, 4619.2.5, 4620.2.5, 4622.2.5, 4623.2.5, 4624.2.5, 4625.2.5, 4626.2.5, 4651.2.5, 4652.2.5, 4653.2.5, 4654.2.5, 4655.2.5, 4657.2.5, 4659.2.5, 4661.2.5, 4665.2.5, 4682.2.5, 4686.2.5, 4688.2.5, 4690.2.5, 4691.2.5, 4694.2.5, 4695.2.5, 4696.2.5, 4698.2.5, 4699.2.5, 4709.2.5, 4758.2.5, 4759.2.5, 4760.2.5, 4761.2.5, 4762.2.5, 4763.2.5, 4764.2.5, 4765.2.5, 4766.2.5, 4767.2.5, 4768.2.5, 4769.2.5, 4770.2.5, 4771.2.5, 4772.2.5, 4773.2.5, 4774.2.5, 4775.2.5, 4778.2.5, 4779.2.5, 4780.2.5, 4781.2.5, 4783.2.5, 4784.2.5, 4785.2.5, 4786.2.5, 4787.2.5, 4788.2.5, 4789.2.5, 4790.2.5, 4792.2.5, 4794.2.5, 4795.2.5, 4796.2.5, 4797.2.5, 4799.2.5, 4804.2.5, 4805.2.5, 4807.2.5, 4814.2.5, 4815.2.5, 4817.2.5, 4818.2.5, 4819.2.5, 4835.2.5, 4839.2.5, 4858.2.5, 4864.2.5, 4889.2.5, 4892.2.5, 4899.2.5, 4912.2.5, 4913.2.5, 4918.2.5, 4927.2.5, 4929.2.5, 4931.2.5, 5063.2.5, 5067.2.5, 5071.2.5, 5183.2.5, 5309.2.5, 5319.2.5, 5323.2.5, 5341.2.5, 5345.2.5, 5353.2.5, 5354.2.5, 5363.2.5, 5377.2.5, 5378.2.5, 5379.2.5, 5380.2.5, 5382.2.5, 5383.2.5, 5385.2.5, 5386.2.5, 5387.2.5, 5388.2.5, 5390.2.5, 5393.2.5, 5398.2.5, 5399.2.5, 5400.2.5, 5403.2.5, 5406.2.5, 5410.2.5, 5411.2.5, 5413.2.5, 5414.2.5, 5415.2.5, 5416.2.5, 5421.2.5, 5424.2.5, 5425.2.5, 4305.2.5, 4415.2.5, 4752.2.5, 4776.2.5, 4854.2.5, 4861.2.5, 4862.2.5, 4867.2.5, 4871.2.5, 4880.2.5, 4893.2.5, 4895.2.5, 4896.2.5, 4901.2.5, 4902.2.5, 4904.2.5, 4906.2.5, 4908.2.5, 4909.2.5, 4938.2.5, 5047.2.5, 5048.2.5, 5049.2.5, 5160.2.5, 5161.2.5, 5162.2.5, 5163.2.5, 5165.2.5, 5166.2.5, 5168.2.5, 5169.2.5, 5170.2.5, 5171.2.5, 5172.2.5, 5173.2.5, 5174.2.5, 5178.2.5, 5179.2.5, 4026.2.5, 4275.2.5, 4346.2.5, 4350.2.5, 4352.2.5, 4353.2.5, 4360.2.5, 4363.2.5, 4369.2.5, 4379.2.5, 4380.2.5, 4381.2.5, 4383.2.5, 4384.2.5, 4385.2.5, 4387.2.5, 4392.2.5, 4395.2.5, 4398.2.5, 4399.2.5, 4401.2.5, 4402.2.5, 4416.2.5, 4417.2.5, 4418.2.5, 4419.2.5, 4420.2.5, 4422.2.5, 4433.2.5, 4441.2.5, 4442.2.5, 4444.2.5, 4447.2.5, 4448.2.5, 4450.2.5, 4454.2.5, 4509.2.5, 4588.2.5, 4590.2.5, 4897.2.5, 5199.2.5, 2731.2.2, 2754.2.2, 2760.2.2, 2789.2.2, 2852.2.2, 2855.2.2, 2859.2.2, 2860.2.2, 2862.2.2, 2863.2.2, 2864.2.2, 2865.2.2, 2866.2.2, 2867.2.2.3, 2868.2.2.3, 2869.2.2, 2870.2.2, 2878.2.2, 2879.2.2, 2880.2.2, 2883.2.2, 2884.2.2, 2885.2.2, 2886.2.2.3, 2887.2.2.3, 2888.2.2, 2890.2.2, 2891.2.2, 2892.2.2, 2893.2.2, 2899.2.2, 2910.2.2, 2912.2.2, 2917.2.2, 2918.2.2, 2922.2.2, 4021.2.5, 4028.2.5, 4029.2.5, 4030.2.5, 4031.2.5, 4036.2.5, 4040.2.5, 4068.2.5, 4084.2.5, 4116.2.5, 4135.2.5, 4138.2.5, 4141.2.5, 4142.2.5, 4143.2.5, 4144.2.5, 4145.2.5, 4146.2.5, 4147.2.5, 4148.2.5, 4149.2.5, 4150.2.5, 4151.2.5, 4152.2.5, 4153.2.5, 4154.2.5, 4155.2.5, 4156.2.5, 4157.2.5, 4159.2.5, 4160.2.5, 4161.2.5, 4163.2.5, 4164.2.5, 4165.2.5, 4166.2.5, 4167.2.5, 4168.2.5, 4169.2.5, 4170.2.5, 4171.2.5, 4172.2.5, 4174.2.5, 4176.2.5, 4177.2.5, 4223.2.5, 4224.2.5, 4225.2.5, 4226.2.5, 4227.2.5, 4243.2.5, 4244.2.5, 4251.2.5, 4253.2.5, 4264.2.5, 4265.2.5, 4271.2.5, 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;
|
| FEI Number |
3013682457
|
Recalling Firm/
Manufacturer |
Turncare, Inc
230 W Parkway Ste 6
Pompton Plains NJ 07444-1060
|
| For Additional Information Contact | Richard Kalita
845-893-6278 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | 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. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
|
|
|
