HEYEX PACS Medical Imaging Software Recall: Measured Values May Be Inaccurate
Medical imaging software HEYEX PACS versions 2.6.0 to 2.6.8 may report measured values smaller than actual area. 474 units distributed nationwide; FDA Class II recall.
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: FDA Class II medical device with a measurement accuracy defect that poses risk of harm to patient care. No illnesses or injuries are reported in the source text. The hazard is theoretical but significant in a safety-critical medical imaging context, meeting the rubric criterion for High severity.
Plain-English summary
The FDA is recalling HEYEX 2 / HEYEX PACS medical imaging software versions 2.6.0 (Build 2088) through 2.6.8 (Build 2220), manufactured by MedicalCommunications GmbH. The software may report measured values that are smaller than the actual area being measured.
This measurement accuracy issue affects medical image management and picture archiving systems used in healthcare settings. Approximately 474 units of the affected software versions were distributed nationwide.
Healthcare facilities and clinicians using affected software should contact MedicalCommunications GmbH or their device supplier for a software update to correct this measurement accuracy issue. Consult the manufacturer or the FDA for guidance on verifying measurements from affected software versions.
The recalled product
- Product
- Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)
- Manufacturer
- MedicalCommunications GmbH
- Hazard
- measurement-accuracy
- imaging-data-integrity
Distribution
Distributed nationwide across the United States.
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