DEXIS Imaging Suite Software Recall for Patient Data Mixing
Imaging Sciences International is recalling DEXIS Imaging Suite software versions 10.0.0 through 10.0.3 due to a defect that can mix patient records during database renumbering.
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 3/5 (High).
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 is classified as FDA Class II. The hazard involves a risk of harm (mixed patient records) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Imaging Sciences International, LLC is recalling 366 units of the DEXIS Imaging Suite, a radiological image processing system. The recall covers catalog number 1.008.7932, specifically software version numbers 10.0.0 through 10.0.3. The affected units were distributed worldwide, including the United States and Canada.
The recall is due to a software defect that can occur during the renumbering of the patient database using the DEXCopy feature. If multiple patients with identical names are present, the software may assign all subsequent records to the first patient record. This results in mixed patient records, which could lead to incorrect medical information being associated with a patient.
Healthcare providers and users of the DEXIS Imaging Suite should contact Imaging Sciences International, LLC for instructions on how to resolve the issue. The source text does not specify a particular corrective action, such as a software patch or replacement, but indicates that the condition requires specific circumstances to occur.
The recalled product
- Product
- DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
- Manufacturer
- Imaging Sciences International, LLC
- Category
- Medical Device — Software
- Affected units
- 366
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 (2)
- Catalog number 1.008.7932
- version numbers 10.0.0 through 10.0.3
Distribution
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