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DRX-Revolution Mobile X-ray System recallZ-0289-2024 · Carestream Health, Inc. · initiated Oct 2, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Carestream Health, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Component design/selection

What the company is doing

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 details

Recall number
Z-0289-2024
Status
Open, Classified
Initiated by the company
Oct 2, 2023
Posted by the FDA
Nov 9, 2023
Recalling firm
Carestream Health, Inc.
Quantity
2402 systems
Product code
IZL
FDA submissions
K191025
Distribution
US Nationwide. Global Distribution.

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.

Code information (models, lots, serial numbers)

Show the full code information (15k characters)

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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Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page