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

Recall 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

U.S. FDA — Device Enforcement · United States · 2019-07-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2484-2019
Date of alert: 2019-07-31
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 in the central control unit of the floor stand.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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