The Recall Desk
HighFDA (Devices)·Z-2463-2012·Announced 2012-10-03

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.

What this means for you

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
Hazard
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

Distributed in 42 states:

Related recalls

Same hazard · data integrity

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