Agency classClass IIOur severity:High FDA (Devices)·Z-0437-2024·Announced 2023-12-13

DRX Revolution Mobile X-Ray System Electrical Component Failure Recall

Carestream Health is recalling the DRX Revolution Mobile X-Ray System due to unexpected failure of electrical components in the CPI generator. The recall affects approximately 3,961 units distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a defect with risk-of-harm potential—unexpected electrical component failure in a critical generator component—where no injuries have been reported. The wide distribution and potential for equipment malfunction justify High severity.

Plain-English summary

Carestream Health, Inc. is recalling the DRX Revolution Mobile X-Ray System due to unexpected failure of electrical components within the CPI generator.

The DRX Revolution Mobile X-Ray System is a portable mobile radiography device used in medical facilities. The manufacturer has identified that electrical components within the CPI generator may experience unexpected failures.

The recall affects approximately 3,961 units distributed worldwide, including throughout the United States and internationally to over 40 countries. Multiple catalog numbers, UDI numbers, and serial numbers are affected by this recall.

Healthcare facilities using affected equipment should contact Carestream Health, Inc. to verify whether their systems are included in the recall using the provided product codes and serial numbers, and for information regarding repair, replacement, or return of the affected systems.

The recalled product

Product: DRX Revolution Mobile X-Ray System
Manufacturer: Carestream Health, Inc.
Category: Medical Device — Radiography / Imaging Equipment
Hazard: electrical-component-failure
equipment-malfunction
Affected units: 3,961

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Catalog No. 1019397
1023423
1030717
1030725
1044726
1060177
8608754
1023415
8610180
8618894
UDI-DI (01)60889971019394(21)2185
(01)60889971019394(21)2186
(01)60889971019394(21)2187
(01)60889971019394(21)2193
(01)60889971019394(21)2194
(01)60889971019394(21)2195
(01)60889971019394(21)2196
(01)60889971019394(21)2200
(01)60889971019394(21)2203
(01)60889971019394(21)2204

Distribution

Distributed nationwide across the United States.

Same manufacturer · Carestream Health, Inc.

See all →

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Same hazard · electrical component failure