Microscope, Surgical
FDA product code EPT · Class I (low risk) · 21 CFR 878.4700 · General, Plastic Surgery
18510(k) clearances
0PMA approvals
13recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942233 | MKM (Multiple Coordinate Manipulator) SystemEPT · Traditional | Carl Zeiss, Inc. | 07/01/1994SE |
| K931284 | Microdyne Office Surgical MicroscopeEPT · Traditional | Microdyne, Inc. | 11/18/1993SE |
| K933310 | Micrins Contrast Background MaterialEPT · Traditional | Micrins Surgical, Inc. | 08/19/1993SE |
| K903412 | Storz Model M705 And/Or M706 Ceiling Mounted Micr.EPT · Traditional | Storz Instrument Co. | 09/20/1990SE |
| K883581 | Opmi CSEPT · Traditional | Carl Zeiss, Inc. | 09/13/1988SE |
| K882269 | Storz Diagnostic Microscope SystemEPT · Traditional | Storz Instrument Co. | 06/23/1988SE |
| K860811 | Zeiss Voice Control System for Opmi'sEPT · Traditional | Carl Zeiss, Inc. | 04/30/1986SE |
| K844858 | Storz/Urban Surgical Microscope SystemEPT · Traditional | Storz Instrument Co. | 03/25/1985SE |
| K832887 | Electronic UnitEPT · Traditional | Surgi-Quip Inc.U | 10/04/1983SE |
| K823011 | VC IIIEPT · Traditional | Teknar, Inc. | 11/08/1982SE |
| K822561 | MicroscopeEPT · Traditional | Treace Medical, Inc. | 09/14/1982SE |
| K822014 | Nagashima Su-A Ceiling Mount Unit forEPT · Traditional | Kelleher Corp. | 08/06/1982SE |
| K822009 | Binocular Operating Microscopes &EPT · Traditional | Kelleher Corp. | 07/30/1982SE |
| K821689 | Lebanon MicroscopeEPT · Traditional | The Lebanon Corp. | 07/09/1982SE |
| K812234 | Storz/Olympus Microscope SystemEPT · Traditional | Storz Instrument Co. | 09/11/1981SE |
| K802904 | Microscope Model Om-UEPT · Traditional | Jedmed Instrument Co. | 02/04/1981SE |
| K802903 | Microscope Model Om-PEPT · Traditional | Jedmed Instrument Co. | 02/04/1981SE |
| K760696 | Remote Control System for MicroscopeEPT · Traditional | Alcon Laboratories | 12/16/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0477-2023 Class II | Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope systemThere is a potential issue resulting in the Power Supply potentially becoming overheated due to internal… | Leica Microsystems, Inc. | 11/21/2022Open, Classified |
| Z-0476-2023 Class II | Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard).…There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal… | Leica Microsystems, Inc. | 11/21/2022Open, Classified |
| Z-2399-2020 Class II | Leica ARveo and M530 OH6 microscope systems.Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in… | Leica Microsystems, Inc. | 05/20/2020Terminated |
| Z-2484-2019 Class II | HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range…software error in the central control unit of the floor stand. | Haag-Streit USA Inc | 07/31/2019Terminated |
| Z-2483-2019 Class II | HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of…software error in the central control unit of the floor stand. | Haag-Streit USA Inc | 07/31/2019Terminated |
| Z-2482-2019 Class II | HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of…software error in the central control unit of the floor stand. | Haag-Streit USA Inc | 07/31/2019Terminated |
| Z-3175-2018 Class II | Leica M525 F20 Surgical Microscope SystemThe firm received complaints that the instrument tipped over when the swing arm was fully extended. | Leica Microsystems, Inc. | 09/04/2018Terminated |
| Z-2555-2018 Class II | Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with…Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas… | Leica Microsystems, Inc. | 06/04/2018Terminated |
| Z-1294-2018 Class II | Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.The microscope may tip over if attachments are fully extended in one line and there is an attempt to move… | Seiler Instr. & Mfg. Co. Inc. | 01/01/2017Open, Classified |
| Z-1440-2013 Class II | Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C…Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope… | Carl Zeiss Meditec, Inc. | 04/18/2013Terminated |
| Z-0105-2012 | OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen…An incorrect nut and bolt set was used in the axis three (3) spring assembly of the OPMI VARIO 700 surgical… | Carl Zeiss Meditec, Inc. | 09/26/2011Terminated |
| Z-3275-2011 | OPMI Pentero, OPMI Pentero C, OPMI Pentero 900, OPMI Vario/S8, OPMI Vario/S88, OPMI…Some third party surgical drapes have optically active protective lenses that could affect the ZEISS… | Carl Zeiss Meditec, Inc. | 09/12/2011Terminated |
| Z-0904-2011 | VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany Medical…Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during… | Carl Zeiss Meditec Inc | 05/18/2009Terminated |