The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radi...
FDA Recall #Z-0289-2024 — Class II — October 2, 2023
Product Description
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films.
Reason for Recall
There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable.
Recalling Firm
Carestream Health, Inc. — Rochester, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2402 systems
Distribution
US Nationwide. Global Distribution.
Code Information
UDI-DI: 60889971019394, Serial Numbers: 1243, 3231, 3232, 3233, 3245, 3246, 3247, 3248, 3249, 3250, 3251, 3252, 3254, 3257, 3260, 3263, 3264, 3265, 3266, 3267, 3270, 3272, 3277, 3285, 3312, 3313, 3317, 3318, 3320, 3321, 3322, 3323, 3324, 3328, 3334, 3465, 3470, 3477, 3489, 3490, 3495, 3496, 3502, 3503, 3506, 3509, 3510, 3511, 3512, 3518, 3521, 3543, 3546, 3548, 3549, 3551, 3552, 3556, 3557, 3563, 3565, 3566, 3572, 3578, 3586, 3587, 3588, 3610, 3611, 3612, 3614, 3617, 3645, 3649, 3650, 3657, 3658, 3660, 3663, 3664, 3671, 3672, 3673, 3686, 3700, 3701, 3703, 3704, 3705, 3706, 3707, 3708, 3709, 3710, 3711, 3712, 3713, 3714, 3715, 3716, 3717, 3721, 3724, 3725, 3730, 3745, 3749, 3750, 3751, 3752, 3753, 3760, 3761, 3762, 3763, 3764, 3766, 3772, 3773, 3776, 3777, 3782, 3783, 3784, 3785, 3793, 3794, 3795, 3798, 3799, 3801, 3802, 3809, 3810, 3814, 3815, 3821, 3826, 3827, 3828, 3829, 3830, 3831, 3833, 3834, 3860, 3864, 3867, 3872, 3875, 3876, 3877, 3878, 3888, 3897, 3898, 3909, 3910, 3911, 3912, 3925, 3937, 3950, 3953, 3961, 3964, 3969, 3974, 3993, 3994, 3995, 3996, 4012, 4030, 4213, 4735, 7616, 818, 3981, 3997, 3998, 4007, 4013, 4014, 4015, 4017, 4021, 4029, 4035, 4045, 4062, 4063, 4070, 4071, 4072, 4073, 4089, 4090, 4097, 4102, 4103, 4116, 4131, 4132, 4133, 4134, 4135, 4136, 4137, 4138, 4139, 4140, 4141, 4142, 4143, 4144, 4145, 4146, 4147, 4148, 4149, 4151, 4152, 4153, 4160, 4161, 4162, 4163, 4164, 4165, 4166, 4167, 4168, 4169, 4171, 4172, 4173, 4175, 4176, 4177, 4178, 4179, 4180, 4181, 4182, 4183, 4184, 4185, 4186, 4187, 4188, 4189, 4190, 4191, 4192, 4193, 4194, 4195, 4196, 4197, 4198, 4199, 4200, 4201, 4202, 4203, 4204, 4205, 4206, 4208, 4210, 4211, 4212, 4214, 4215, 4217, 4218, 4219, 4220, 4223, 4224, 4225, 4226, 4227, 4228, 4229, 4230, 4231, 4234, 4235, 4236, 4237, 4240, 4241, 4242, 4243, 4244, 4245, 4246, 4247, 4248, 4249, 4250, 4251, 4252, 4253, 4254, 4255, 4256, 4257, 4259, 4260, 4262, 4263, 4267, 4268, 4269, 4270, 4271, 4272, 4275, 4276, 4277, 4278, 4279, 4280, 4281, 4320, 4321, 4322, 4323, 4324, 4326, 4327, 4328, 4329, 4405, 4424, 4445, 4446, 4447, 4448, 4449, 4556, 4557, 4558, 4559, 4560, 4561, 4562, 4563, 4564, 4565, 4566, 4567, 4568, 4569, 4570, 4571, 4572, 4573, 4574, 4575, 4576, 4577, 4578, 4579, 4580, 4581, 4582, 4583, 4584, 4585, 4586, 4587, 4588, 4589, 4590, 4591, 4592, 4593, 4594, 4595, 4596, 4597, 4598, 4599, 4600, 4601, 4602, 4603, 4604, 4605, 4606, 4607, 4608, 4609, 4610, 4611, 4612, 4613, 4614, 4615, 4616, 4617, 4618, 4619, 4620, 4621, 4622, 4623, 4624, 4625, 4626, 4627, 4628, 4629, 4630, 4631, 4632, 4633, 4634, 4635, 4636, 4637, 4638, 4639, 4640, 4641, 4642, 4643, 4644, 4645, 4646, 4647, 4648, 4649, 4650, 4651, 4652, 4653, 4654, 4655, 4656, 4657, 4658, 4659, 4660, 4661, 4662, 4663, 4664, 4665, 4666, 4667, 4668, 4669, 4670, 4671, 4672, 4673, 4674, 4675, 4676, 4677, 4678, 4679, 4680, 4681, 4682, 4683, 4684, 4685, 4686, 4687, 4688, 4689, 4690, 4691, 4692, 4694, 4695, 4696, 4697, 4698, 4699, 4700, 4701, 4702, 4703, 4704, 4705, 4706, 4707, 4708, 4709, 4713, 4714, 4715, 4716, 4717, 4718, 4719, 4720, 4721, 4722, 4723, 4724, 4725, 4726, 4728, 4729, 4730, 4736, 4737, 4738, 4739, 4740, 4741, 4742, 4743, 4744, 4745, 4746, 4749, 4750, 4751, 4752, 4753, 4755, 4756, 4757, 4758, 4759, 4760, 4761, 4762, 4763, 4764, 4765, 4766, 4767, 4768, 4769, 4770, 4771, 4772, 4773, 4774, 4775, 4776, 4777, 4778, 4779, 4780, 4781, 4782, 4783, 4790, 4791, 4792, 4793, 4794, 4797, 4798, 4800, 4801, 4802, 4803, 4804, 4805, 4806, 4807, 4808, 4809, 4810, 4811, 4812, 4813, 4814, 4815, 4816, 4817, 4818, 4819, 4820, 4821, 4823, 4824, 4825, 4829, 4832, 4833, 4834, 4835, 4836, 4837, 4838, 4839, 4840, 4841, 4842, 4843, 4844, 4845, 4846, 4847, 4848, 4849, 4850, 4851, 4852, 4853, 4854, 4855, 4856, 4857, 4859, 4865, 4866, 4867, 4868, 4869, 4870, 4871, 4872, 4873, 4874, 4875, 4876, 4878, 4879, 4880, 4881, 4882, 4883, 4884, 4886, 7361, 7378, 7379, 7380, 7384, 7385, 8541, 3115, 3116, 3117, 3180, 3236, 3237, 3238, 3239, 3240, 3241, 3242, 3243, 3244, 3253, 3255, 3256, 3258, 3261, 3262, 3268, 3269, 3271, 3273, 3274, 3275, 3276, 3278, 3281, 3283, 3286, 3287, 3288, 3289, 3290, 3291, 3292, 3295, 3296, 3297, 3298, 3299, 3300, 3301, 3302, 3303, 3304, 3305, 3306, 3307, 3308, 3309, 3310, 3314, 3315, 3316, 3319, 3330, 3331, 3333, 3335, 3466, 3467, 3468, 3469, 3471, 3472, 3473, 3474, 3475, 3476, 3478, 3479, 3484, 3485, 3491, 3492, 3493, 3494, 3497, 3498, 3499, 3504, 3505, 3513, 3514, 3515, 3516, 3517, 3519, 3522, 3523, 3524, 3525, 3527, 3528, 3529, 3530, 3539, 3547, 3550, 3553, 3554, 3555, 3558, 3559, 3560, 3561, 3567, 3568, 3569, 3570, 3571, 3573, 3574, 3575, 3577, 3579, 3580, 3581, 3582, 3583, 3584, 3585, 3589, 3590, 3591, 3592, 3593, 3594, 3595, 3596, 3597, 3598, 3599, 3600, 3601, 3602, 3603, 3604, 3605, 3606, 3607, 3613, 3615, 3616, 3618, 3619, 3620, 3621, 3622, 3623, 3624, 3625, 3626, 3627, 3628, 3629, 3630, 3631, 3632, 3633, 3634, 3635, 3636, 3637, 3638, 3639, 3640, 3641, 3642, 3643, 3644, 3646, 3647, 3648, 3651, 3652, 3653, 3654, 3655, 3656, 3659, 3665, 3666, 3667, 3668, 3669, 3670, 3674, 3675, 3676, 3677, 3678, 3679, 3680, 3681, 3682, 3683, 3684, 3685, 3687, 3688, 3689, 3690, 3691, 3692, 3693, 3694, 3695, 3696, 3698, 3699, 3722, 3723, 3726, 3727, 3728, 3729, 3731, 3732, 3733, 3734, 3735, 3736, 3737, 3738, 3739, 3740, 3741, 3742, 3743, 3744, 3754, 3755, 3757, 3758, 3759, 3765, 3767, 3769, 3770, 3771, 3778, 3779, 3780, 3786, 3787, 3788, 3789, 3790, 3791, 3792, 3796, 3797, 3800, 3803, 3804, 3805, 3806, 3807, 3808, 3811, 3812, 3817, 3818, 3819, 3820, 3822, 3823, 3824, 3825, 3837, 3838, 3839, 3840, 3841, 3842, 3843, 3844, 3845, 3846, 3847, 3848, 3849, 3850, 3851, 3852, 3853, 3854, 3855, 3856, 3857, 3858, 3859, 3865, 3866, 3868, 3869, 3870, 3871, 3873, 3874, 3879, 3884, 3885, 3886, 3887, 3889, 3890, 3891, 3892, 3893, 3894, 3895, 3896, 3899, 3900, 3901, 3902, 3903, 3904, 3905, 3906, 3907, 3913, 3914, 3915, 3916, 3917, 3918, 3919, 3920, 3921, 3922, 3923, 3924, 3926, 3927, 3928, 3929, 3930, 3931, 3932, 3933, 3934, 3935, 3936, 3938, 3939, 3940, 3941, 3942, 3943, 3944, 3947, 3948, 3949, 3952, 3954, 3955, 3956, 3957, 3958, 3959, 3960, 3965, 3966, 3967, 3968, 3970, 3971, 3972, 3973, 3975, 3976, 3977, 3983, 3984, 3990, 3992, 4006, 4009, 4010, 4027, 4031, 4032, 4034, 4041, 4042, 4043, 4044, 7344, 7443, 8575, 197, 1103, 1684, 1728, 1924, 1925, 2451, 3363, 3978, 3979, 3980, 3982, 3985, 3986, 3987, 3988, 3989, 3991, 3999, 4000, 4001, 4002, 4003, 4004, 4005, 4011, 4018, 4019, 4020, 4022, 4024, 4025, 4026, 4028, 4033, 4036, 4037, 4038, 4039, 4040, 4047, 4048, 4049, 4050, 4051, 4052, 4053, 4054, 4055, 4056, 4057, 4059, 4060, 4061, 4064, 4065, 4066, 4067, 4068, 4069, 4074, 4075, 4077, 4078, 4079, 4080, 4081, 4082, 4083, 4085, 4086, 4088, 4091, 4092, 4093, 4094, 4095, 4096, 4098, 4099, 4100, 4101, 4104, 4106, 4107, 4108, 4109, 4110, 4111, 4112, 4113, 4114, 4120, 4121, 4122, 4123, 4124, 4125, 4126, 4127, 4128, 4129, 4130, 4154, 4155, 4156, 4157, 4158, 4159, 4216, 4221, 4222, 4232, 4233, 4238, 4239, 4258, 4264, 4265, 4266, 4273, 4274, 4282, 4283, 4284, 4285, 4286, 4287, 4288, 4289, 4290, 4291, 4292, 4293, 4294, 4295, 4296, 4297, 4298, 4299, 4300, 4301, 4302, 4303, 4304, 4305, 4306, 4307, 4308, 4309, 4310, 4311, 4312, 4313, 4314, 4315, 4316, 4317, 4318, 4319, 4330, 4331, 4332, 4333, 4334, 4335, 4337, 4338, 4339, 4340, 4341, 4342, 4343, 4344, 4345, 4346, 4347, 4348, 4349, 4350, 4351, 4352, 4353, 4354, 4355, 4356, 4357, 4358, 4359, 4360, 4361, 4362, 4363, 4364, 4365, 4366, 4367, 4368, 4369, 4370, 4371, 4372, 4373, 4374, 4375, 4376, 4377, 4378, 4379, 4380, 4381, 4382, 4383, 4384, 4385, 4386, 4387, 4388, 4389, 4390, 4391, 4392, 4393, 4394, 4395, 4396, 4397, 4398, 4399, 4400, 4401, 4402, 4403, 4406, 4407, 4408, 4409, 4410, 4411, 4412, 4413, 4414, 4415, 4416, 4417, 4418, 4419, 4420, 4421, 4422, 4423, 4425, 4426, 4427, 4428, 4429, 4430, 4431, 4432, 4433, 4434, 4435, 4436, 4437, 4438, 4439, 4440, 4441, 4442, 4443, 4444, 4450, 4451, 4452, 4453, 4454, 4455, 4456, 4457, 4458, 4460, 4461, 4462, 4463, 4464, 4465, 4466, 4467, 4468, 4469, 4470, 4471, 4472, 4473, 4474, 4475, 4476, 4477, 4478, 4479, 4480, 4481, 4482, 4483, 4484, 4485, 4486, 4487, 4488, 4489, 4490, 4491, 4492, 4493, 4494, 4495, 4496, 4497, 4498, 4499, 4500, 4501, 4502, 4503, 4504, 4505, 4506, 4507, 4508, 4509, 4510, 4511, 4512, 4513, 4514, 4515, 4516, 4517, 4518, 4519, 4520, 4521, 4522, 4523, 4524, 4525, 4526, 4527, 4529, 4530, 4531, 4532, 4533, 4534, 4535, 4536, 4537, 4538, 4539, 4540, 4541, 4542, 4543, 4544, 4545, 4546, 4547, 4548, 4549, 4550, 4551, 4552, 4553, 4554, 4555, 4727, 4747, 4748, 4754, 4784, 4785, 4786, 4787, 4788, 4789, 4795, 4799, 4827, 4830, 4831, 7067, 7079, 800672; UDI-DI: 60889978618897, Serial Numbers: 7001, 7016, 7021, 7031, 7032, 7054, 7060, 7075, 7084, 7085, 7093, 7094, 7095, 7114, 7115, 7116, 7118, 7119, 7143, 7144, 7145, 7146, 7147, 7148, 7149, 7150, 7152, 7153, 7154, 7155, 7156, 7157, 7158, 7160, 7161, 7167, 7168, 7169, 7170, 7171, 7172, 7173, 7174, 7180, 7181, 7182, 7184, 7185, 7186, 7203, 7204, 7208, 7209, 7223, 7224, 7225, 7233, 7234, 7235, 7236, 7237, 7243, 7244, 7245, 7246, 7247, 7248, 7249, 7250, 7251, 7268, 7269, 7270, 7281, 7282, 7283, 7285, 7286, 7287, 7292, 7294, 7299, 7301, 7303, 7304, 7312, 7313, 7314, 7315, 7319, 7320, 7321, 7322, 7323, 7330, 7331, 7355, 7356, 7357, 7358, 7359, 7360, 7362, 7363, 7365, 7366, 7367, 7368, 7372, 7381, 7383, 7392, 7393, 7405, 7428, 7431, 7437, 7446, 7447, 7448, 7463, 7464, 7491, 7505, 7506, 7514, 7517, 7518, 7534, 7535, 7536, 7537, 7538, 7539, 7540, 7541, 7542, 7543, 7544, 7545, 7546, 7547, 7548, 7554, 7560, 7561, 7562, 7563, 7572, 7573, 7574, 7575, 7576, 7577, 7578, 7579, 7580, 7581, 7582, 7583, 7585, 7586, 7588, 7589, 7590, 7591, 7592, 7594, 7595, 7597, 7600, 7602, 7603, 7604, 7605, 7606, 7607, 7608, 7609, 7610, 7611, 7623, 7624, 7625, 7629, 7634, 7643, 7644, 7650, 7651, 7665, 7666, 7667, 7668, 7669, 7673, 7686, 7687, 7688, 7689, 7691, 7692, 7693, 7694, 7714, 7722, 7723, 7724, 7725, 7727, 7728, 7729, 7763, 7764, 7765, 7766, 7778, 7779, 7780, 7781, 7783, 7784, 7785, 7786, 7787, 7788, 7789, 7790, 7791, 7792, 7796, 7801, 7812, 7829, 7830, 7831, 7832, 7833, 7834, 7835, 7848, 7849, 7850, 7851, 7868, 7869, 7870, 7885, 7886, 7889, 7890, 7891, 7901, 7902, 7904, 7907, 7909, 7910, 7911, 7917, 7919, 7921, 7937, 7938, 7946, 7947, 7952, 7953, 7954, 7967, 7969, 7974, 7975, 7976, 7977, 7996, 8005, 8006, 8007, 8008, 8009, 8010, 8017, 8018, 8021, 8059, 8071, 8089, 8102, 8117, 20003, 20004, 20005, 20006, 20007, 20008, 20009, 20010, 20011, 20012, 20013, 20014, 20016, 20019, 20020, 20021, 20023, 20025, 20026, 20027, 20029, 20031, 20032, 20034, 20037, 20038, 20042, 20044, 20048, 20049, 20050, 7006, 7007, 7009, 7010, 7011, 7012, 7013, 7014, 7015, 7017, 7018, 7019, 7020, 7022, 7023, 7024, 7025, 7026, 7027, 7028, 7029, 7030, 7033, 7034, 7035, 7036, 7037, 7038, 7039, 7040, 7041, 7042, 7043, 7044, 7045, 7046, 7047, 7048, 7049, 7050, 7051, 7052, 7053, 7055, 7056, 7057, 7058, 7059, 7061, 7062, 7063, 7064, 7065, 7066, 7068, 7069, 7070, 7071, 7072, 7073, 7074, 7076, 7077, 7078, 7080, 7081, 7082, 7083, 7086, 7087, 7088, 7089, 7090, 7091, 7092, 7096, 7097, 7098, 7099, 7100, 7101, 7102, 7103, 7104, 7105, 7106, 7107, 7108, 7109, 7110, 7111, 7112, 7113, 7117, 7122, 7123, 7124, 7125, 7126, 7127, 7128, 7129, 7130, 7131, 7132, 7133, 7134, 7135, 7136, 7137, 7138, 7139, 7140, 7141, 7142, 7151, 7159, 7162, 7163, 7164, 7165, 7166, 7175, 7176, 7177, 7178, 7187, 7188, 7189, 7190, 7191, 7192, 7193, 7194, 7195, 7196, 7197, 7198, 7199, 7200, 7201, 7202, 7210, 7211, 7212, 7213, 7214, 7215, 7216, 7217, 7218, 7219, 7220, 7221, 7222, 7227, 7228, 7229, 7230, 7231, 7232, 7239, 7240, 7241, 7242, 7252, 7253, 7254, 7255, 7256, 7258, 7259, 7260, 7261, 7262, 7263, 7264, 7265, 7266, 7267, 7271, 7272, 7273, 7274, 7275, 7276, 7277, 7278, 7279, 7288, 7289, 7290, 7291, 7295, 7296, 7297, 7298, 7305, 7306, 7307, 7308, 7309, 7310, 7311, 7316, 7317, 7318, 7324, 7325, 7326, 7327, 7328, 7329, 7332, 7333, 7334, 7335, 7336, 7337, 7338, 7339, 7340, 7341, 7342, 7343, 7345, 7346, 7347, 7348, 7349, 7350, 7351, 7352, 7353, 7354, 7369, 7373, 7374, 7375, 7376, 7377, 7386, 7387, 7388, 7389, 7390, 7391, 7394, 7395, 7396, 7397, 7398, 7399, 7400, 7401, 7402, 7403, 7404, 7406, 7407, 7408, 7409, 7410, 7411, 7412, 7413, 7414, 7415, 7416, 7418, 7420, 7421, 7422, 7423, 7424, 7425, 7426, 7427, 7429, 7430, 7432, 7433, 7434, 7435, 7436, 7439, 7440, 7441, 7442, 7444, 7445, 7450, 7451, 7452, 7453, 7454, 7455, 7456, 7457, 7458, 7459, 7460, 7461, 7462, 7465, 7466, 7467, 7468, 7469, 7470, 7471, 7472, 7473, 7474, 7475, 7476, 7477, 7478, 7479, 7480, 7481, 7482, 7483, 7484, 7485, 7486, 7487, 7488, 7489, 7490, 7492, 7493, 7494, 7496, 7497, 7498, 7499, 7500, 7501, 7503, 7504, 7507, 7508, 7509, 7510, 7511, 7512, 7513, 7515, 7516, 7519, 7520, 7521, 7522, 7523, 7524, 7526, 7527, 7528, 7529, 7530, 7531, 7532, 7533, 7549, 7550, 7551, 7552, 7553, 7555, 7556, 7557, 7558, 7559, 7564, 7565, 7566, 7567, 7568, 7569, 7570, 7584, 7587, 7593, 7612, 7613, 7614, 7618, 7619, 7620, 7621, 7626, 7627, 7628, 7631, 7632, 7633, 7635, 7637, 7638, 7639, 7640, 7641, 7645, 7647, 7648, 7649, 7652, 7653, 7654, 7656, 7657, 7659, 7660, 7661, 7662, 7663, 7670, 7672, 7674, 7675, 7676, 7677, 7678, 7679, 7680, 7681, 7682, 7683, 7695, 7696, 7697, 7698, 7699, 7700, 7701, 7702, 7703, 7704, 7705, 7706, 7707, 7708, 7709, 7710, 7711, 7712, 7713, 7715, 7716, 7717, 7718, 7719, 7731, 7732, 7733, 7734, 7735, 7736, 7737, 7738, 7739, 7741, 7742, 7743, 7744, 7745, 7746, 7747, 7748, 7749, 7750, 7751, 7752, 7753, 7754, 7755, 7757, 7758, 7759, 7760, 7761, 7762, 7767, 7768, 7770, 7771, 7772, 7773, 7774, 7775, 7776, 7777, 7793, 7794, 7795, 7797, 7798, 7799, 7800, 7802, 7803, 7804, 7805, 7806, 7807, 7808, 7809, 7810, 7811, 7813, 7814, 7815, 7816, 7817, 7818, 7836, 7838, 7839, 7840, 7841, 7842, 7843, 7844, 7845, 7846, 7847, 7853, 7854, 7855, 7856, 7857, 7858, 7859, 7860, 7861, 7862, 7863, 7864, 7865, 7866, 7871, 7872, 7874, 7875, 7876, 7877, 7878, 7879, 7880, 7881, 7882, 7883, 7884, 7887, 7888, 7892, 7893, 7894, 7895, 7896, 7898, 7899, 7900, 7915, 7916, 7922, 7923, 7924, 7925, 7926, 7927, 7928, 7929, 7930, 7931, 7932, 7933, 7934, 7935, 7936, 7955, 7966, 7968, 7979, 7980, 7981, 7982, 7983, 7984, 7985, 7986, 7987, 7988, 7989, 7990, 7991, 7993, 7994, 7995, 7997, 7998, 7999, 8000, 8001, 8002, 8003, 8022, 8023, 8024, 8025, 8026, 8027, 8028, 8029, 8030, 8031, 8032, 8033, 8034, 8035, 8036, 8037, 8039, 8040, 8041, 8042, 8043, 8044, 8045, 8060, 8061, 8062, 8065, 8066, 8077, 8078, 8079, 8080, 8081, 8082, 8083, 8084, 8091, 8092, 8094, 8095, 8097, 8105
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.