DRX-Revolution Mobile X-Ray System Generator May Overheat Unexpectedly
Carestream Health is recalling 2,402 DRX-Revolution Mobile X-Ray Systems due to potential electrical failure in the generator causing thermal overload. The system becomes inoperable and may produce loud noise, burnt smell, and smoke.
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: FDA Class II diagnostic device with potential for electrical component failure causing thermal overload and smoke generation. No injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Carestream Health, Inc. is recalling 2,402 DRX-Revolution Mobile X-Ray Systems distributed nationwide and globally. This diagnostic mobile x-ray system is used for acquiring medical images outside of standard x-ray rooms and features a wireless flat-panel detector technology with self-contained x-ray generator.
The recall addresses a potential for unexpected failure of electrical components within the x-ray generator. This failure can lead to a temporary, self-contained thermal overload within the generator unit, which will cause the system to become inoperable.
If a thermal overload occurs, users may observe loud noise, burnt smell, and smoke emanating from the generator. No injuries or illnesses related to this issue have been reported to date.
Facilities using affected DRX-Revolution systems should verify their serial numbers against the recall notification. Customers should contact Carestream Health, Inc. for instructions regarding repair or replacement options for their equipment.
The recalled product
- Product
- 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 st
- Manufacturer
- Carestream Health, Inc.
- Hazard
- thermal-overload
- electrical-failure
- fire-hazard
- device-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)
- UDI-DI: 60889971019394
- Serial Numbers: 1243
- 3231
- 3232
- 3233
- 3245
- 3246
- 3247
- 3248
- 3249
- 3250
- 3251
- 3252
- 3254
- 3257
- 3260
- 3263
- 3264
- 3265
- 3266
Distribution
Distributed nationwide across the United States.
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