Leica Microsystems, Inc.
Deerfield, IL, US
LEICA MICROSYSTEMS, INC. appears in FDA device records in Deerfield, IL. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 60 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Leica Microsystems, Inc. between 1999 and 2006. The busiest year on record is 1999, with 1. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2006 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1423337 | 3000210133 | LEICA MICROSYSTEMS, INC. | 10 Parkway North Blvd., Deerfield, IL 60015 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 60| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0477-2023 | Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system | There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown. | Class II | Open, Classified | |
| Z-0476-2023 | Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system | There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown. | Class II | Open, Classified | |
| Z-0475-2023 | Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system | There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown. | Class II | Open, Classified | |
| Z-1851-2022 | Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950 | 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. | Class II | Open, Classified | |
| Z-1850-2022 | Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 | 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. | Class II | Open, Classified | |
| Z-1849-2022 | Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 | 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. | Class II | Open, Classified | |
| Z-1848-2022 | Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 | 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. | Class II | Open, Classified | |
| Z-0412-2022 | Leica Microsystems M220 F12 Microscope Systems | In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient. | Class II | Terminated | |
| Z-2481-2021 | BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375 | Product may not perform as specified in IFU. | Class II | Terminated | |
| Z-2399-2020 | Leica ARveo and M530 OH6 microscope systems. | Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage. | Class II | Terminated | |
| Z-0673-2020 | BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system. | BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining. | Class II | Open, Classified | |
| Z-1729-2019 | Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications. | The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and can cause serious injuries. | Class II | Terminated | |
| Z-0772-2019 | Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. | The M220 optics may unintentionally drop into the surgical field, risking contact with the patient. | Class II | Terminated | |
| Z-0281-2019 | BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments | The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound. | Class II | Terminated | |
| Z-0019-2019 | Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics. | Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock. | Class II | Terminated | |
| Z-3175-2018 | Leica M525 F20 Surgical Microscope System | The firm received complaints that the instrument tipped over when the swing arm was fully extended. | Class II | Terminated | |
| Z-2659-2018 | Leica M530 OHX Microscope System Supplied with 100 - 120 Vac. | Recall is due to a design weakness of the power insert module. | Class II | Terminated | |
| Z-0064-2019 | Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens. | These devices have an incorrect specification against safety standard ISO61010-1. Should a single fault error occur, a mains wire can contact a metal plate which is accessible to the user. This could lead to mains power on the metal plate resulting in hazardous voltage to the user. | Class II | Terminated | |
| Z-2555-2018 | Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied for observation and documentation and for human and veterinary medical treatment. Not for use in Eye Operations. | Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier. | Class II | Terminated | |
| Z-0838-2019 | PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. | The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or sporadic failures in the proper on-screen display functionality of the HDR recording unit. Additionally, an anomaly in the device software may also lead to the unexpected behavior that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. This behavior can only occur in unlikely workflows where a user changes a user profile or a mode change is initiated at the same time as a functional button is activated. | Class II | Terminated | |
| Z-2660-2017 | Nussloch GmbH ASP6025 Tissue Processor | Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit. | Class II | Open, Classified | |
| Z-1877-2016 | Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues. | Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling. | Class II | Terminated | |
| Z-1876-2016 | Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation. | Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling. | Class II | Terminated | |
| Z-1704-2016 | Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections. | Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining. | Class II | Terminated | |
| Z-1499-2016 | 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. | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain