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Leica M525 F20 Surgical Microscope System

FDA Device Recall #Z-3175-2018 — Class II — September 4, 2018

Recall Summary

Recall Number Z-3175-2018
Classification Class II — Moderate risk
Date Initiated September 4, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Leica Microsystems, Inc.
Location Buffalo Grove, IL
Product Type Devices
Quantity 160 units

Product Description

Leica M525 F20 Surgical Microscope System

Reason for Recall

The firm received complaints that the instrument tipped over when the swing arm was fully extended.

Distribution Pattern

US and Canada

Lot / Code Information

Serial Numbers: 10714001 10813001 11010001 11010002 20312001 20316001 20513001 20518001 20813001 20911002 20916001 30112001 30412001 30616001 30813001 30813002 40112001 40310001 40510001 40610001 40916001 41215001 50218001 50813001 51011001 51015001 51116001 60218001 60317001 60415001 60813001 70116002 70414001 70714001 71010001 71011001 80114001 80212002 80316001 80513001 80611001 80817001 81014001 90317001 90610001 91117001 91215001 100310001 100317001 100616001 101211001 101216001 110110001 110112001 110116001 110310001 110517001 110809001 110816001 120116001 121216001 130313001 130813001 131010002 131011001 131115001 131211001 131212001 131216001 131216002 140214001 140413001 140612001 140813001 141209001 150415001 150612001 150813001 151013001 151116002 151210001 151211001 151211002 151215001 160216001 160313001 160418001 160810001 160911001 161210002 170310001 170809001 170811001 170916001 170917001 180116001 180117001 180213001 180216001 180511001 180610001 180612001 181111001 190214002 190309001 190316001 190813001 200418001 200910001 210115001 210214001 210316001 211010001 220715001 220909001 220916001 221010002 230909001 230910001 230916001 231109001 231116001 231213001 240712001 240713001 250218001 250414001 250510001 250516001 250814001 250816001 250914001 260514001 260815002 260914001 270810001 280118001 280217001 280411001 280414001 280513001 280910002 280911001 281111001 281113001 290116001 290212001 290515001 290713001 290817001 290817002 290912001 300414001 300418001 300516001 300713001 300816001 310514001 310810001 310815001 The following serial numbers were added in October, 2018. 140415001 170415001 170415002 40714001 170212001 70116001 70513001 90513001

Other Recalls from Leica Microsystems, Inc.

Recall # Classification Product Date
Z-0477-2023 Class II Leica MICROSYSTEMS M530 OHX, Part Number 104487... Nov 21, 2022
Z-0476-2023 Class II Leica MICROSYSTEMS Provido, Part Numbers 104489... Nov 21, 2022
Z-0475-2023 Class II Leica MICROSYSTEMS Proveo 8, Part Number 104490... Nov 21, 2022
Z-1849-2022 Class II Leica Surgical Operating Microscopes, Arveo, Pa... Aug 26, 2022
Z-1848-2022 Class II Leica Surgical Operating Microscopes, ARveo 8, ... Aug 26, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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