HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage:… — Class II medical device recall Z-2483-2019
Terminated recall by Haag-Streit USA Inc, reported 2019-09-11. software error in the central control unit of the floor stand.
| Recall number | Z-2483-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haag-Streit USA Inc, Mason, OH, United States |
| Recall initiated | 2019-07-31 |
| Classified | 2019-09-05 |
| Reported by FDA | 2019-09-11 |
| Terminated | 2020-04-16 |
| Quantity | 0 |
| Reason classes | software |
| Serial numbers | 10.1.XX, 101, 11.3.XX, 360, 376 |
| Model numbers | 586, 615 |
Product
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.
Reason for recall
software error in the central control unit of the floor stand.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2483-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.