The Recall Desk
HighFDA (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.

What this means for you

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

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.

Related recalls

Same category