HOROS MOBILE
ICAT SOLUTIONS LTD · Model HOROS MOBILE · UDI-DI 05070002336815
Description
The Falcon MD is an interactive medical image display software device for diagnostic image viewing of radiological images for the following modalities: X-ray, CT, MRI, Ultrasound, and XA for iOS and iPadOS platforms. The technological characteristics and the indications of use are identical to those of the Horos MD™ (K232589). The subject device provides both 2D and 3D image visualization tools for CT and MRI scans from various makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system. The device is intended to be operated by radiologists, clinicians and other qualified physicians.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-10 | INTELERAD MEDICAL SYSTEMS INCORPORATED | A cybersecurity vulnerability has been identified in the software that could allow a malicious user to take over an administrator session, delete or modify image or study data, or |
| 2026-09-05 | INTELERAD MEDICAL SYSTEMS INCORPORATED | Following a Chromium-based web-browser, report and displayed images may not match. |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be |
| 2026-07-31 | GE Healthcare | Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be |
| 2026-07-22 | Merge Healthcare, Inc. | Software issue may cause measurements to be displayed inaccurately. |
| 2026-07-22 | FUJIFILM Healthcare Americas Corporation | Software issue may cause the ruler measurement to be inaccurate. |
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