Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0697-2021 — 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 i

U.S. FDA — Device Enforcement · United States · 2020-11-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0697-2021
Date of alert: 2020-11-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Haag-Streit USA Inc
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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