Carestream Health, Inc.: 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.

Recall number

Z-0289-2024

Recalling firm

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.

Status

Open, Classified

Initiated

2023-10-02

Posted

2023-11-09

Terminated

not on file

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.

Root cause

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

2402 systems

Distribution

US Nationwide. Global Distribution.

Lot, serial or model codes

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, 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510(k) numbers

["K191025"]

PMA numbers

not on file

Product code

IZL

Firm FEI

1317307

Firm city

Rochester

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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