Carestream DRX Revolution Mobile X-Ray System Column Cover Recall
Carestream Health is recalling DRX Revolution mobile x-ray systems because the column end cover may dislodge from the column.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
Carestream Health Inc. is conducting a recall for the DRX Revolution Mobile X-Ray System. The recall involves the Column end Cover, which is present on the device.
The recall is being conducted because the cover may dislodge from the column. The affected devices are designed to perform radiographic x-ray examinations on all pediatric and adult patients in all patient treatment areas.
The recall includes 331 units with serial numbers manufactured between June 21, 2012, and June 12, 2013. The devices were distributed nationwide in the United States and in various international locations. Users should contact Carestream Health for instructions on how to address the defect.
The recalled product
- Product
- DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas
- Manufacturer
- Carestream Health Inc.
- Category
- Medical Device — X-Ray Equipment
- Hazard
- Affected units
- 331
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 (3)
- Serial Numbers: All serial numbers manufactured since inception in June 21
- 2012 until June 12
- 2013
Distribution
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