Carestream DRX Evolution System Recalled for Unintended X-Ray Exposure
Carestream Health Inc. is recalling four DRX Evolution System units because they allowed x-ray exposures without an image receptor, resulting in two exposures before an image was captured.
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 (unintended radiation exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Carestream Health Inc. is recalling four units of the DRX Evolution System (Standard Q). These are permanently installed diagnostic x-ray systems used for examining various anatomical regions. The recall covers units with serial numbers 5049, 5073, 5133, and 5162, which were distributed nationwide, including in Texas, Illinois, and Georgia.
The recall was initiated after Carestream received a report that an x-ray exposure was initiated without a patient image being captured. In this specific incident, the patient was imaged two times before an image was successfully captured. A field engineer who visited the site reported that the system allowed an exposure without the assignment of a bucky or image receptor.
Healthcare facilities that have these specific serial numbers should contact Carestream Health Inc. for further instructions on how to address the issue.
The recalled product
- Product
- Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems…
- Manufacturer
- Carestream Health Inc.
- Affected units
- 4
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 (4)
- Serial Numbers 5049
- 5073
- 5133
- 5162
Distribution
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