Carestream Health, Inc.: DRX-Revolution Mobile X-Ray Systems Recalled for Generator Thermal Overload

Agency Publication Date: November 9, 2023

Summary

Carestream Health is recalling approximately 2,402 DRX-Revolution Mobile X-Ray Systems because a failure in the electrical components within the generator can cause a thermal overload. This defect can cause the mobile medical device to stop working suddenly, often accompanied by a loud noise, a burnt smell, and detectable smoke. These diagnostic mobile systems were distributed globally and nationwide across the United States to healthcare facilities for acquiring medical images outside of standard X-ray rooms.

Risk

The internal generator can undergo a thermal overload, causing the system to become completely inoperable during a medical procedure. While the heat is self-contained, the resulting smoke, burnt odors, and loud noises may cause alarm or distress to patients and staff in a clinical environment.

What You Should Do

Check your device for UDI-DI 60889971019394 or 60889978618897 and verify if your serial number is included in the affected list (e.g., 1243, 3231, 7001, 7016, 20003, and over 2,000 others).
If your system experiences a sudden failure accompanied by a loud noise, burnt smell, or smoke, immediately stop using the device and move it away from patients.
Contact your healthcare facility's clinical engineering department or the manufacturer, Carestream Health, Inc., to report the event and schedule service.
Contact Carestream Health, Inc. at their Rochester, New York headquarters or through their official service channels for further instructions regarding the generator components.
Consult your healthcare provider if you have concerns regarding a delay in diagnostic imaging caused by an inoperable system.
For additional information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer correction/service

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: DRX-Revolution Mobile X-Ray System

Model / REF:

Z-0289-2024

UPC Codes:

60889971019394

60889978618897

Lot Numbers:

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, 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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, 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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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93253

Status: Active

Manufacturer: Carestream Health, Inc.

Sold By: Authorized Medical Device Distributors; Direct Hospital Sales

Manufactured In: United States

Units Affected: 2402 systems

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Summary

What You Should Do

Check your device for UDI-DI 60889971019394 or 60889978618897 and verify if your serial number is included in the affected list (e.g., 1243, 3231, 7001, 7016, 20003, and over 2,000 others).

If your system experiences a sudden failure accompanied by a loud noise, burnt smell, or smoke, immediately stop using the device and move it away from patients.

Contact your healthcare facility's clinical engineering department or the manufacturer, Carestream Health, Inc., to report the event and schedule service.

Contact Carestream Health, Inc. at their Rochester, New York headquarters or through their official service channels for further instructions regarding the generator components.

Consult your healthcare provider if you have concerns regarding a delay in diagnostic imaging caused by an inoperable system.

For additional information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.