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.
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: 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 compo
- 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
Related recalls
Same manufacturer · Carestream Health Inc.
See all →- HighDRX Revolution Mobile X-Ray System Electrical Component Failure Recall
FDA (Devices) · 2023-12-13
- HighDRX-Revolution Mobile X-Ray System Generator May Overheat Unexpectedly
FDA (Devices) · 2023-11-15
- HighX-ray System Overhead Crane May Continue Moving Unexpectedly
FDA (Devices) · 2023-03-08
- HighCarestream Recalls Kodak DirectView DR3000/3500 X-Ray Systems for U-Arm Movement
FDA (Devices) · 2020-01-22
- ModerateCarestream OnSight 3D Extremity System Recalled for Software Data Error
FDA (Devices) · 2019-05-01
Same hazard · unintended radiation exposure
See all →- HighRadiation Therapy Software May Not Properly Execute Heart-Protection Breath Hold
FDA (Devices) · 2023-03-22
- HighGE Healthcare Recalls Innova IGS 540 ACT X-ray Systems
FDA (Devices) · 2017-06-21
- HighAmerican Science & Engineering Recalls Gemini Cabinet X-ray Systems
FDA (Devices) · 2015-08-26