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

Recall Z-1848-2022 — Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063

U.S. FDA — Device Enforcement · United States · 2022-08-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1848-2022
Date of alert
2022-08-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Leica Microsystems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
30622001
Reported risk: During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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