Aesculap
Upgrade KIT F/Integration OF 3D Monitor
11manufacturers in China registered for this device type
4catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Jiangsu Dynamic Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 12 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Chengdu Corder Optics & Electronics Co., Ltd. | Chengdu | Sichuan | Manufacturer | 1 |
| Hefei MAX ACT Medical Equipment Co., Ltd. | Hefei | Anhui | Manufacturer | 1 |
| Shanghai Eder Medical Technology Inc. | Shanghai | Shanghai | Manufacturer | 1 |
| Suzhou Semorr Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | FSO |
| Device type | Microscope, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-06-29 |
| Record revised | 2026-04-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2022-04-13 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PV011 | In distribution | |
| PV022 | In distribution | |
| PV010 | In distribution | |
| PV032SU | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| zumax | Zumax Medical Co., Ltd. | 130 |
| MaxView System – Lateral Set | Viseon, Inc. | 7 |
| S100 / Opmi pico | Carl Zeiss Meditec Inc | 6 |
| S7 / Opmi PROergo | Carl Zeiss Meditec Inc | 6 |
| Atmos | Atmos Medizintechnik Gmbh & Co. KG | 4 |
| MaxView™ System – Lateral Set with Illumination | Viseon, Inc. | 3 |
| S7 / Opmi Sensera | Carl Zeiss Meditec Inc | 3 |
| Medical Microscope | Denjoy Dental Co., Ltd. | 3 |
| RoboticScope | Bhs Intl., Inc. | 2 |
| Rols Reinverter – Leica+ | Volk Optical Inc. | 2 |
| Rols Reinverter – Zeiss + | Volk Optical Inc. | 2 |
| MaxView 4K, Lateral Imager | Viseon, Inc. | 2 |
Showing 12 of 130. All products under Microscope, Surgical, General & Plastic Surgery
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Aesculap AG | UDI-DI | 2024-05-13 | Class II | Process control | 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 safety mechanism. | 19 units |
| Aesculap AG | UDI-DI | 2021-02-19 | Class II | Material/Component Contamination | Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system. | 1 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-07-14 | Class II | Software design | Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available: | 5 units | 2025-02-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.