CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report

The DRX-Revolution Mobile X-Ray System is a diagnostic recalled

Carestream Health is recalling The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing, distributed nationwide in the US. The recall was initiated on 2 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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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Quantity recalled2402 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0289-2024
FDA event ID: 93253
Recalling firm: Carestream Health, Rochester, NY
Classification: Class II
Status: Ongoing
Recall initiated: 2 Oct 2023
FDA classified: 9 Nov 2023
Reported: 15 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

2 Oct 2023	Recall initiated by company
9 Nov 2023	Classified by FDA	+38 days
15 Nov 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide. Global Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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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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, 7203, 7204, 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Where was it sold?

US Nationwide. Global Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Carestream Health

All 86

Reported	Class	Recall	Company	Reason	Where
13 Dec 2023Device	CLASS II	DRX Revolution Mobile X-Ray System recalled by Carestream Health	Carestream Health	Device Malfunction	Nationwide
8 Mar 2023Device	CLASS II	Drx-Compass/Dr-fit X-ray Systems with Firmware recalled	Carestream Health	Other	Nationwide
22 Jan 2020Device	CLASS II	Kodak DirectView DR3000/3500 recalled by Carestream Health	Carestream Health	Other	IA
1 May 2019Device	CLASS II	OnSight 3D Extremity System- X-Ray, Tomography Computed System recalled	Carestream Health	Other	Nationwide
5 Jul 2017Device	CLASS II	DRX-Revolution Mobile X-Ray System recalled by Carestream Health	Carestream Health	Other	Nationwide

Other Imaging Equipment recalls

All 2,347

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide