Carestream DRX-Revolution Mobile X-Ray Systems Recalled for Image Retrieval Failure
Carestream Health Inc. is recalling 310 mobile X-ray systems because processed images could not be found, leading to patient re-exposure.
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 risk-of-harm product (excessive radiation exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Carestream Health Inc. is recalling 310 DRX-Revolution Mobile X-Ray Systems manufactured in the United States. The recall was initiated after the company received a report from a customer indicating that processed images were unable to be found in the system. This technical failure resulted in two different patients being re-exposed to X-rays.
The affected units are mobile diagnostic X-ray systems designed for radiographic examinations of pediatric and adult patients. The recall covers systems manufactured between June 2012 and October 2013, with specific serial numbers listed in the agency's documentation. These products were distributed nationwide.
Consumers and healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, it should be removed from service and the manufacturer contacted for further instructions.
The recalled product
- Product
- Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.…
- Manufacturer
- Carestream Health Inc.
- Affected units
- 310
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)
- 111
- 114
- 119
- 121
- 122
- 123
- 125
- 126
- 134
- 142
- 143
- 151
- 152
- 153
- 154
- 155
- 161
- 162
- 163
- 164
Distribution
Distributed nationwide across the United States.
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