Carestream DRX-Revolution Mobile X-Ray System Recalled for Broken Bolts
Carestream Health is recalling 629 DRX-Revolution Mobile X-Ray Systems because bolts securing the x-ray tube assembly may break, posing a risk of equipment failure.
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: The recall involves a structural defect in a medical device where a component may break, posing a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Carestream Health, Inc. is recalling 629 units of the DRX-Revolution Mobile X-Ray System, Model DRXR-1. The recall covers units with serial numbers 101 to 764. The affected devices are mobile imaging systems used to acquire medical diagnostic images outside of standard x-ray rooms.
The recall was initiated after a field engineer discovered a broken bolt from the carriage assembly while servicing a unit at a customer site. Carestream identified that bolts securing the x-ray tube assembly and boom to the device mounting block may break. The company determined this issue is the result of an improperly assembled part that holds the x-ray tube.
The recalled units were distributed worldwide, including in the United States and 28 other countries. There are 358 domestic units and 271 foreign units involved in this recall. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray…
- Manufacturer
- Carestream Health Inc
- Hazard
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 (1)
- Serial Numbers 101 to 764
Distribution
Distributed nationwide across the United States.
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