The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR)…

Reason

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.…

Status

Ongoing

Distribution

US Nationwide. Global Distribution.

Enforcement report date

Nov. 15, 2023

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)

Filed by

Carestream Health, Inc.

Product

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

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.

Distribution pattern

US Nationwide. Global Distribution.

Quantity

2402 systems

Codes and lots

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…

The first 12,000 characters of this field; the agency record has the rest.

Recall started

Oct. 2, 2023

Voluntary or mandated

Voluntary: Firm initiated

Device type

System, X-Ray, Mobile

Root cause (FDA)

Component design/selection

What the company told customers

An MEDICAL DEVICE FIELD CORRECTIVE ACTION notification letter dated 9/27/23 was sent to customers. Actions To Be Taken by User Facility: " Inform all personnel that utilize the system of the potential issue. " Should an event of this nature occur: o Move the system away from patients/staff. o The system will be inoperable. o Call the Carestream Customer Care Center in the U.S. at 1-800-328-2910, your local Carestream Service support number or Carestream Health Authorized Representative to place a service call. " If an Adverse Health Event is encountered, notify FDA MedWatch o MedWatch: Use the MedWatch Online Reporting Form to report adverse events or call 800-332-1088. o If outside the US, notify the local competent authority in your region. " Review and complete the Consignee Notification Acknowledgement form as instructed. Corrective Action to Be Taken by Carestream: You will be contacted by a Carestream Service Engineer or Carestream Health Authorized Representative to schedule a time for your system(s) to be serviced. At the scheduled time, a Carestream Service Engineer or Carestream Health Authorized Representative will inspect your DRX-Revolution Mobile X-ray System and replace generator component(s) which will resolve the identified Carestream generator issue. If you have any questions or concerns please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24-hour basis. Outside of the U.S., please call your local Carestream Service support number. If you have distributed the device outside your facility, please alert your customer(s) of this Field Corrective Action and contact the Carestream Customer Care Center as instructed above.

Recall number

Z-0289-2024

If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.

FDA device name: System, X-Ray, Mobile

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement report, recall number Z-0289-2024. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

FDA recall record Z-0289-2024, Nov. 15, 2023. "The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR)." PlainRecords, https://plainrecords.com/recall/device/z-0289-2024/ (as of the day it was built).

At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections