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S7 / OPMI Sensera

Carl Zeiss Meditec AG · Model 000000-1087-851 · UDI-DI 04049539104151

FSO

510(k) clearances

165

Adverse events (1 deaths)

Recalls

Facilities

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 safety mechanism.
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 suspension arm, which may inj
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 inaccurate adjustment o
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 inaccurate adjustment o
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 inaccurate adjustment o
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 inaccurate adjustment o
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 complaint. However,
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 smell emanating from

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.