FDA Device recall Z-1499-2016
Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope
- FDA Device
- Class II
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class II recall of Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope by Leica Microsystems, citing an electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and smell emanating fro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1499-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Leica Microsystems |
| Distribution | US |
Product
Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
Reason
An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.
Identifiers
| code_info | OH5-51313; OH4-112214; OH5-49112; OH5-67914; OH4-101213; OH5-20238; OH4-91913; OH5-43312; OH5-54113; OH5-64514; OH4-103…OH5-51313; OH4-112214; OH5-49112; OH5-67914; OH4-101213; OH5-20238; OH4-91913; OH5-43312; OH5-54113; OH5-64514; OH4-103014; OH4-106514; OH4-87112; OH4-95413; OH4-94213; OH4-106014; OH4-105514; OH4-94813; OH4-102514; OH4-91113; OH4-87312; OH4-106714; OH5-62113; OH5-46112; OH5-50512; OH4-85912; OH4-81512; OH5-61013; OH5-53913; OH4-95013; OH4-91413; OH4-110614; OH4-94613; OH4-104714; OH4-87212; OH4-85712; OH5-50212; OH4-96213; OH4-88913; OH4-89613; OH5-55113; OH4-99413; OH5-48112; OH4-90713; OH5-66314; OH5-68314; OH4-109414; OH4-83912; OH5-48012; OH4-101313; OH4-86812; OH5-60113; OH5-60313; OH5-37311; OH4-86612; OH5-62913; OH4-95813; OH4-90613; OH4-103614; OH5-48212; OH5-48312; OH5-58313; OH5-53513; OH5-63313; OH4-92613; OH5-43812; OH5-56713; OH5-68114; OH4-81412; OH4-98013; OH5-33911; OH5-61913; OH5-52813; OH4-110714; OH5-46312; OH5-51113; OH4-106814; OH4-112714; OH5-63514; OH5-39012; OH5-63013; OH4-111614; OH4-97013; OH4-97613; OH4-107414; OH4-109514; OH4-109614; OH4-92513; OH4-104614; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Leica Microsystems
- Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
FDA Device · Class II · 2022-12-21 · Leica Microsystems - Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
FDA Device · Class II · 2022-12-21 · Leica Microsystems - Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard)
FDA Device · Class II · 2022-12-21 · Leica Microsystems - Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
FDA Device · Class II · 2022-10-05 · Leica Microsystems - Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
FDA Device · Class II · 2022-10-05 · Leica Microsystems
All Leica Microsystems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1499-2016%22
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