FDA Device recall Z-2053-2012
Leica M525 F50 Surgical Microscope
- FDA Device
- Class II
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class II recall of Leica M525 F50 Surgical Microscope by Leica Microsystems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2053-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-04 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Leica Microsystems |
| Distribution | US |
Product
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 observation and documentation and for human and veterinary medical treatment.
Reason
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.
Identifiers
| code_info | Serial numbers serial numbers 110311001, 120312001, 20412001, 260112001, 300911001, 40811001, 80411001, 90312001, 10311…Serial numbers serial numbers 110311001, 120312001, 20412001, 260112001, 300911001, 40811001, 80411001, 90312001, 10311002, 90611001, 260711001, 20911001, 200911001, 210911001, 111011001, 141011001, 241011001, 121211001, 141211001, 151211001, 191211001, 30112001, 50112001, 140212001, 60312001, 220312001, 300312001, 30412001, 50411001, 10411001, 130411001, 210411001, 170511001, 300511001, 90811001, 200312001, 50412001, 110112002, 280611001, 241011002, 20312001, 101011001 and 270911001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 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-2053-2012%22
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