Carestream DRX Mobile X-Ray Systems Recalled for Software Defect
Carestream Health is voluntarily patching DRX Mobile X-Ray systems to fix a software issue causing non-diagnostic images.
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: The recall is a voluntary field action to address a software defect resulting in non-diagnostic images. There are no reported injuries, illnesses, or deaths, and the hazard is limited to diagnostic accuracy rather than 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 recall affects 364 units of the DRX-Mobile Retrofit Kit (Catalog number 1019397) manufactured in the U.S.A. These systems are used to perform radiographic x-ray examinations on pediatric and adult patients.
The field action is being performed because Carestream received reports of non-diagnostic images on exams when a Normal Exposure setting was used. The issue occurs when the systems are equipped with DirectView Version 5.5 and 5.6 console software and used with DRX-1 Detector version 69 firmware. The affected serial numbers are all units manufactured with version 5.5 software and version 69 firmware.
The affected units were distributed nationwide to facilities in 42 states and the District of Columbia. Consumers and healthcare providers should contact Carestream Health to schedule the installation of the software patch.
The recalled product
- Product
- CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. 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
- 364
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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