Carestream Health, Inc. Recall 93253
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.
Carestream Health, Inc. Recall 93253 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0289-2024 |
| Event ID | 93253 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide. Global Distribution. |
| Quantity | 2402 systems |
| Recall 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. |
| Device Classification | 20231115 |
| Device Code Info | 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, 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| Center Classification Date | 20231109 |
| Recall Initiation Date | 20231002 |
| Recalling Firm | Carestream Health, Inc. |
| Initial Notification | Letter |
| Similar To |