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

Recall Z-2053-2012 — Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for obse

U.S. FDA — Device Enforcement · United States · 2012-06-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2053-2012
Date of alert: 2012-06-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Leica Microsystems, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 110311001

Reported risk: Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is used in combination with a remote control connected to a remote video adapter or motorized dual video adapter.

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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