Carestream OnSight 3D Extremity System Recalled for Software Data Error
Carestream Health is recalling 37 OnSight 3D Extremity Systems because a software error may leave companion imaging volumes in the original patient's exam during re-assignment.
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 classified as FDA Class II. The hazard is a software data integrity error that does not involve a high-risk pathogen, structural defect, or reported injuries, fitting the criteria for a moderate severity recall.
Plain-English summary
Carestream Health, Inc. is recalling 37 units of the OnSight 3D Extremity System, an x-ray computed tomography and projection x-ray imaging device. The affected catalog numbers are 1743566 (with attached console) and 1743574 (with remote console). The device is intended for imaging the upper and lower extremities of adult patients and pediatric patients aged 12 and over.
The recall is due to a software defect that occurs when a user performs the re-assignment of a parent/companion pair. In this scenario, the parent volume is correctly transferred to the new patient, but the companion volume remains in the original patient's exam. This error could result in incorrect data association within the imaging system.
The affected units were distributed worldwide, including in the United States (Arizona, California, New York, Alabama, Georgia, Illinois, Minnesota, Oregon, and Pennsylvania) and in several international locations including Iran, Italy, Jerusalem, Korea, the Philippines, Portugal, Saudi Arabia, Singapore, Switzerland, Thailand, and the United Kingdom. Specific US and overseas serial numbers are listed in the official recall documentation. Users should contact Carestream Health for instructions on correcting the software issue.
The recalled product
- Product
- OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult…
- Manufacturer
- Carestream Health, Inc.
- Affected units
- 37
Distribution
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