Haag-Streit LENSTAR LS900 Software Recall for Data Mixing Errors
Haag-Streit USA Inc is recalling Eyesuite 9.3.1 software for LENSTAR LS900 devices due to potential mixing of patient names and examination data.
What this means for you
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, but the hazard is a data integrity error (mixing up names and data) rather than a direct physical injury or high-risk pathogen, fitting the Moderate category for minor labeling or data errors without reported physical harm.
Plain-English summary
Haag-Streit USA Inc is recalling Eyesuite 9.3.1 software used with the LENSTAR, MODEL LS900 ac-powered slit-lamp biomicroscope. The recall is due to a defect where examination data and patient names may be mixed up when printing or generating a PDF using the interface at Pacific Coast and Laser Institute (PCLI).
The affected software is version 9.3.1. The distribution pattern is listed as US Nationwide distribution in the state of WA. This issue involves the integrity of patient records rather than a direct physical hazard to the patient during the examination itself.
Consumers and healthcare providers should contact the recalling firm, Haag-Streit USA Inc, for further instructions on how to resolve the software issue.
The recalled product
- Product
- Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
- Manufacturer
- Haag-Streit USA Inc
- Hazard
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 (1)
- Software version 9.3.1
Distribution
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