Carestream DRX-Revolution Mobile X-Ray Systems Software Patch Recall
Carestream Health is voluntarily installing a software patch on DRX-Revolution mobile X-ray systems to address reports of non-diagnostic images during normal exposure exams.
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 2/5 (Moderate).
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: This is a voluntary precautionary recall for a software defect that results in non-diagnostic images. There are no reported injuries, illnesses, or deaths, and the hazard is limited to equipment functionality rather than direct physical harm.
Plain-English summary
Carestream Health Inc. is conducting a voluntary field action to install a software patch on specific DRX-Revolution Mobile X-Ray, DRX-Mobile, and DRX Transportable Systems. The action affects systems using DirectView Version 5.5 and 5.6 console software in combination with DRX-1 Detector version 69 firmware.
The recall was initiated after Carestream received reports of non-diagnostic images occurring during exams when a Normal Exposure setting was used. This issue may affect the ability to obtain clear diagnostic images from the equipment.
The affected units were distributed nationwide to various states and the District of Columbia. Healthcare facilities using these specific models and software/firmware versions should contact Carestream Health to schedule the installation of the necessary software patch.
The recalled product
- Product
- DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
- Manufacturer
- Carestream Health Inc.
- Affected units
- 190
Distribution
Part of a larger recall action
This product is one of 2 recalled by Carestream Health Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
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