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CALLISTO eye

Carl Zeiss Meditec AG · Model 3.6.2 · UDI-DI 04049539104403

NFJ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2025-09-09	MedicalCommunications GmbH	Potential that the measured value may be smaller than the actual area.
2024-09-17	Topcon Medical Systems, Inc.	The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function
2022-01-11	Diagnos Inc	Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prio
2020-12-18	Topcon Medical Systems, Inc.	Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient records and images to be
2020-11-03	Kowa Optimed Inc	It has been determined that the software distributed with the retinal camera may delete patient information. Specifically, if multiple IDs are delated at the same time, their is a
2019-03-06	Topcon Medical Systems, Inc.	When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is completed, then the primary patient's thu
2017-06-13	Merge Healthcare, Inc.	When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user att
2017-01-05	Haag-Streit USA Inc	There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
2016-04-04	Merge Healthcare, Inc.	The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
2016-04-04	Merge Healthcare, Inc.	During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanentl

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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.