Haag Streit Surgical Floor stands FS 2-11 — Class II medical device recall Z-0697-2021
Ongoing recall by Haag-Streit USA Inc, reported 2020-12-30, distributed nationwide. Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing th
| Recall number | Z-0697-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haag-Streit USA Inc, Mason, OH, United States |
| Recall initiated | 2020-11-20 |
| Classified | 2020-12-23 |
| Reported by FDA | 2020-12-30 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Reason classes | software |
| Serial numbers | 2-15, 615H515, 820, 821, 900A |
| Model numbers | 588, 615, 615H511, 615H515, 657, 820, 821 |
Product
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view
Reason for recall
Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye
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-0697-2021. 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.