Ophthalmic imaging software recalled over measured areas smaller than actual values
MedicalCommunications GmbH is recalling 474 units of HEYEX 2 / HEYEX PACS software because a measured value may be smaller than the actual area.
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: Scored 3 under the risk-of-harm criterion: an area measurement reported smaller than actual can misinform clinical assessment, and no injuries are reported.
Plain-English summary
The Ashvins variant of HEYEX 2 / HEYEX PACS, a medical image management and picture archiving and communication system, is being recalled for software versions 2.6.0 (Build 2088) through 2.6.8 (Build 2220).
There is a potential that the measured value may be smaller than the actual area.
The recall covers 474 units carrying UDI-DI 4260648620046, distributed nationwide in the United States. The FDA has classified the action as Class II.
Sites running the affected software versions should follow the manufacturer's instructions and treat area measurements from those versions with caution until the software is updated.
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
- Affected units
- 474
Distribution
Distributed nationwide across the United States.
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