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.
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 2/5 (Moderate).
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
Related recalls
Same manufacturer · Haag-Streit USA Inc
See all →- HighOCT-Camera Laser Shut-Off Malfunction Poses Patient Safety Risk
FDA (Devices) · 2022-01-19
- HighOCT Camera Laser Safety Shut-Off Malfunction Affects Three Units
FDA (Devices) · 2022-01-19
- HighHaag-Streit Surgical Floor Stands Recalled for Software Error
FDA (Devices) · 2020-12-30
- ModerateHaag-Streit Recalls HS Hi-R NEO 900 Operating Microscopes Due to Software Error
FDA (Devices) · 2019-09-11
- HighHaag-Streit Operating Microscope Floor Stand Software Error Recall
FDA (Devices) · 2019-09-11
Same hazard · data integrity error
See all →- HighGE Healthcare Recalls Centricity PACS Server V7 Due to Data Association Error
FDA (Devices) · 2026-09-23
- HighGE Healthcare radiological imaging system patient information mismatch
FDA (Devices) · 2023-05-10
- ModerateSiemens DCA Vantage Barcode Scanner Recalled for Data Integrity Issues
FDA (Devices) · 2020-08-12
- ModerateHitachi Oasis MRI System Recalled for Image Data Transfer Errors
FDA (Devices) · 2017-03-29
- HighBio-Rad D-10 Rack Loader Recalled for Potential Sample ID Error
FDA (Devices) · 2016-02-03
Similar recalls
- ModerateHaag-Streit EyeSuite Software Recalled for Potential Patient Data Misattribution
FDA (Devices) · 2017-03-29
- HighHaag-Streit Surgical Floor Stands Recalled for Software Error
FDA (Devices) · 2020-12-30
- ModerateHaag-Streit Recalls HS Hi-R NEO 900A Operating Microscopes Due to Software Error
FDA (Devices) · 2019-09-11
- ModerateHaag-Streit Recalls HS Hi-R NEO 900 Operating Microscopes Due to Software Error
FDA (Devices) · 2019-09-11
- HighHaag-Streit Operating Microscope Floor Stand Software Error Recall
FDA (Devices) · 2019-09-11
- HighHitachi VidiStar PACS Software Recalled for Potential Image Mix-Up
FDA (Devices) · 2018-09-12