CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
Guardian 2 System Guardian System 2 Controller recalled by Turncare
Turncare is recalling Guardian 2 System Guardian System 2 Controller, distributed nationwide in the US. The recall was initiated on 1 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1967-2025
- FDA event ID
- 96873
- Recalling firm
- Turncare, Pompton Plains, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Nov 2023
- FDA classified
- 12 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 1 Nov 2023 | Recall initiated by company | |
| 12 Jun 2025 | Classified by FDA | +589 days |
| 18 Jun 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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)
Where it was distributed
US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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, 2897.2.2, 2900.2.2.3, 2904.2.2, 2906.2.2, 2907.2.2, 2908.2.2, 2909.2.2, 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, 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, 4119.2.5, 4120.2.5, 4121.2.5, 4122.2.5, 4124.2.5, 4125.2.5, 4126.2.5, 4127.2.5, 4128.2.5, 4129.2.5, 4130.2.5, 4131.2.5, 4132.2.5, 4133.2.5, 4134.2.5, 4136.2.5, 4137.2.5, 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, 4188.2.5, 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, 4210.2.5, 4211.2.5, 4212.2.5, 4214.2.5, 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, 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, 4367.2.5, 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, 4430.2.5, 4431.2.5, 4434.2.5, 4435.2.5, 4436.2.5, 4437.2.5, 4439.2.5, 4443.2.5, 4478.2.5, 4481.2.5, 4484.2.5, 4487.2.5, 4490.2.5, 4491.2.5, 4492.2.5, 4493.2.5, 4494.2.5, 4528.2.5, 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, 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, 4763.2.5, 4764.2.5, 4765.2.5, 4766.2.5, 4767.2.5, 4768.2.5, 4770.2.5, 4771.2.5, 4772.2.5, 4773.2.5, 4774.2.5, 4775.2.5, 4777.2.5, 4779.2.5, 4780.2.5, 4781.2.5, 4782.2.5, 4783.2.5, 4784.2.5, 4785.2.5, 4786.2.5, 4787.2.5, 4788.2.5, 4789.2.5, 4790.2.5, 4858.2.5, 4892.2.5, 5341.2.5, 5345.2.5, 5354.2.5, 5382.2.5, 5387.2.5, 5390.2.5, 5393.2.5, 5414.2.5, 5416.2.5, 5421.2.5, 5425.2.5, 2131.01, 2150.01, 2233.01, 2238.01, 2549.01, 2575.2.2.3, 2778.2.2, 2782.2.2.3, 2785.2.2.3, 2881.2.2.3, 2940.2.2.3, 2950.2.2.3, 3040.2.2.3, 3065.2.2.3, 4266.2.5, 4267.2.5, 4268.2.5, 4269.2.5, 4276.2.5, 4283.2.5, 4288.2.5, 4290.2.5, 4291.2.5, 4292.2.5, 4295.2.5, 4296.2.5, 4297.2.5, 4298.2.5, 4299.2.5, 4300.2.5, 4301.2.5, 4302.2.5, 4303.2.5, 4307.2.5, 4309.2.5, 4829.2.5, 4846.2.5, 4026.2.5, 4275.2.5, 4346.2.5, 4350.2.5, 4352.2.5, 4353.2.5, 4354.2.5, 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, 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, 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, 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, 4158.2.5, 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, 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, 4609.2.5, 4627.2.5, 4628.2.5, 4629.2.5, 4630.2.5, 4631.2.5, 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, 4724.2.5, 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, 2014.01, 2137.01, 2166.01, 2207.01, 2215.01, 2255.01, 2258.01, 2262.01, 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, 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, 4827.2.5, 4828.2.5, 4830.2.5, 4831.2.5, 4832.2.5, 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, 4847.2.5, 4848.2.5, 4849.2.5, 4850.2.5, 4879.2.5, 4882.2.5, 2151.01, 2161.01, 2185.01, 2205.01, 2245.01, 2332.01, 2341.01, 2354.01, 2366.01, 2373.01, 2441.01, 2446.01, 2448.01, 2463.01, 2481.01, 2506.01, 2507.01, 2522.01, 2537.01, 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, 2733.2.2, 2735.2.2, 2736.2.2, 2739.2.2, 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, 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;
Where was it sold?
US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Turncare
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Guardian 2 System Guardian System 2 Controller recalled by Turncare | Turncare | Device Malfunction | Nationwide |
Other Medical Software recalls
All 932| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Device Malfunction | CA |
| Device | CLASS II | Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Upgrade to MR recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |