Haag-Streit HS Hi-R NEO 900A NIR Software Error Recall: Risk of Incorrect Surgical
Haag-Streit recalls specific models of surgical microscopes with software errors that may cause incorrect surgical measurements during procedures. Affected units include certain FS 2-21, FS 2-25, and FS 3-45 floor stands with specific serial numbers and software versions.
Use caution until it’s fixed
software error in the central control unit of the floor stand.
Contact the company
What happened, in plain English
Haag-Streit is recalling specific models of surgical microscopes that have a software error in the central control unit. This error could lead to incorrect surgical measurements during procedures, which might affect patient safety. Read more at govinfonow.com/recall/67270-haag-streit-hs-hi-r-neo-900a-nir-software-error.
Source Summary by GovInfoNow · govinfonow.com/recall/67270-haag-streit-hs-hi-r-neo-900a-nir-software-error · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2484-2019
Cite this page
“Haag-Streit HS Hi-R NEO 900A NIR Software Error Recall: Risk of Incorrect Surgical.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67270-haag-streit-hs-hi-r-neo-900a-nir-software-error. Based on FDA recall #Z-2484-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2484-2019%22&limit=1).
Why it’s dangerous
The software error in the central control unit can cause incorrect surgical measurements when used with specific floor stands (FS 2-21, FS 2-25, FS 3-45) and software versions 10.1.xx to 11.3.xx. This may lead to unintended surgical outcomes if the error affects critical measurements during procedures.
Who’s affected
Surgical professionals using Haag-Streit HS Hi-R NEO 900A NIR microscopes with specific floor stands and software versions are most at risk. Patients undergoing procedures with these affected devices may experience inaccurate measurements.
How to tell if you have this one
Check if your microscope has the model HS Hi-R NEO 900A NIR with the floor stand model FS 2-21, FS 2-25, or FS 3-45. Look for serial numbers and software versions listed in the recall notice: serial numbers from 101 to 360 or 361, and software versions 10.1.xx to 11.3.xx.
- Brand
Haag-Streit- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US in the state of OH
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2482-2019 | HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.; The Error only occurs in combination with the following floor stands FS 2-21, FS 2-25, FS 3-45 with the software REF 615 586 in the versions 10.1.xx to 11.3.xx 1. Product: FS 2-21, Reference # 615 510 Serial # 101 to 360, SW-Version: 10.1.xx to 11.3.xx 2. Product: FS 2-21, Reference # 615 510, serial # from 361 3. Product: FS 2-25, Reference # 615 550, Serial # 101 to 376, SW Version: 10.1.xx to 11.3.xx 4. Product: FS 2-25, Reference # 615 550, Serial # from 377 4. Product: FS 3-45, Reference # 615 705, Serial #from 101 | 0 |
| Z-2483-2019 | HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.; The Error only occurs in combination with the following floor stands FS 2-21, FS 2-25, FS 3-45 with the software REF 615 586 in the versions 10.1.xx to 11.3.xx 1. Product: FS 2-21, Reference # 615 510 Serial # 101 to 360, SW-Version: 10.1.xx to 11.3.xx 2. Product: FS 2-21, Reference # 615 510, serial # from 361 3. Product: FS 2-25, Reference # 615 550, Serial # 101 to 376, SW Version: 10.1.xx to 11.3.xx 4. Product: FS 2-25, Reference # 615 550, Serial # from 377 4. Product: FS 3-45, Reference # 615 705, Serial #from 101 | 0 |
| Z-2484-2019 | HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.; The Error only occurs in combination with the following floor stands FS 2-21, FS 2-25, FS 3-45 with the software REF 615 586 in the versions 10.1.xx to 11.3.xx 1. Product: FS 2-21, Reference # 615 510 Serial # 101 to 360, SW-Version: 10.1.xx to 11.3.xx 2. Product: FS 2-21, Reference # 615 510, serial # from 361 3. Product: FS 2-25, Reference # 615 550, Serial # 101 to 376, SW Version: 10.1.xx to 11.3.xx 4. Product: FS 2-25, Reference # 615 550, Serial # from 377 4. Product: FS 3-45, Reference # 615 705, Serial #from 101 | 1 |
What to do — step by step
Check Software Version
Verify your microscope's software version by checking the device settings or documentation. The affected versions are 10.1.xx to 11.3.xx.
Contact Manufacturer
Reach out to Haag-Streit USA Inc for guidance on whether your specific unit is affected and what steps to take next.
Where it went and when
Where it was distributed
Distributed in Ohio.
FDA distribution: “US in the state of OH” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Ohio.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2484-2019 (July 31, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2484-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.