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U.S. Department of Health and Human Services

Class 2 Device Recall DRXRevolution

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  Class 2 Device Recall DRXRevolution see related information
Date Initiated by Firm October 02, 2023
Date Posted November 09, 2023
Recall Status1 Open3, Classified
Recall Number Z-0289-2024
Recall Event ID 93253
510(K)Number K191025  
Product Classification System, x-ray, mobile - Product Code IZL
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.
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, 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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, 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Recalling Firm/
Manufacturer
Carestream Health, Inc.
1049 W Ridge Rd
Rochester NY 14615-2731
Manufacturer 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.
FDA Determined
Cause 2
Component design/selection
Action 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.
Quantity in Commerce 2402 systems
Distribution US Nationwide. Global Distribution.
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.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = Carestream Health Inc.
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