Home › Device types › FSO
Microscope, Surgical, General & Plastic Surgery
FDA product code FSO · Class 1 · General, Plastic Surgery
295
Registered devices
168
Adverse events
17
Recalls
15
510(k) clearances
Devices with this code
zumax — Zumax Medical Co., LTDS100 / OPMI pico — Carl Zeiss Meditec AGzumax — Zumax Medical Co., LTDzumax — Zumax Medical Co., LTDzumax — Zumax Medical Co., LTDM822 C40 / M822 CT40 / M844 C40 / M844 CT40 — Leica Microsystems (Schweiz) AGMerlin RA Mount, Zeiss MD — VOLK OPTICAL INC.Mounting Kit, MediWorks SM621 — VOLK OPTICAL INC.Merlin Mount, Zeiss — VOLK OPTICAL INC.Mounting Kit, Takagi OM-19 — VOLK OPTICAL INC.zumax — Zumax Medical Co., LTDzumax — Zumax Medical Co., LTDS7 / OPMI Sensera — Carl Zeiss Meditec AGzumax — Zumax Medical Co., LTDMerlin RA Mount, Leica 690 — VOLK OPTICAL INC.Imager Adaptor for Alphatec PTP™ Retractor — VISEON, INC.ROLS Reinverter - Leica+ — VOLK OPTICAL INC.Labomed Prima DNT Microscope Floor Mount Fixed — LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDVolk SOLR Small Wide Angle Lens — VOLK OPTICAL INC.zumax — Zumax Medical Co., LTDzumax — Zumax Medical Co., LTDMerlin CLA, Manual, 175 mm — VOLK OPTICAL INC.KINEVO 900 S — Carl Zeiss Meditec AGAESCULAP — Aesculap AG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-13 | Aesculap Inc | Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safet |
| 2023-08-18 | Carl Zeiss Suzhou Co., Ltd. | Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspensio |
| 2022-08-26 | Leica Microsystems, Inc. | 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 ina |
| 2022-08-26 | Leica Microsystems, Inc. | 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 ina |
| 2022-08-26 | Leica Microsystems, Inc. | 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 ina |
| 2022-08-26 | Leica Microsystems, Inc. | 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 ina |
| 2022-07-14 | Aesculap Implant Systems LLC | Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available: |
| 2021-11-03 | Leica Microsystems, Inc. | 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 |
| 2021-02-19 | Aesculap Implant Systems LLC | Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system. |
| 2016-01-11 | Leica Microsystems, Inc. | An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and |
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