Imaging: FDA Approvals, Recalls, 510(k) Clearances and Side…

1,520device recalls (since 1 Jan 2023)
354510(k) clearances (since 1 Jan 2023)

Each number has its full source under its own list below.

Device recalls

1,520 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

12Oct2026
Interventional Fluoroscopic X-Ray System
Reason: Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
Z-0289-2027
12Oct2026
Interventional Fluoroscopic X-Ray System
Reason: Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
Z-0290-2027
12Oct2026
Interventional Fluoroscopic X-Ray System
Reason: Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
Z-0291-2027
6Oct2026
Interventional Fluoroscopic X-Ray System
Reason: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduce…
Z-0292-2027
6Oct2026
Interventional Fluoroscopic X-Ray System
Reason: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduce…
Z-0293-2027
6Oct2026
Interventional Fluoroscopic X-Ray System
Reason: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduce…
Z-0294-2027
6Oct2026
Interventional Fluoroscopic X-Ray System
Reason: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduce…
Z-0295-2027
6Oct2026
Interventional Fluoroscopic X-Ray System
Reason: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduce…
Z-0296-2027
6Oct2026
Interventional Fluoroscopic X-Ray System
Reason: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduce…
Z-0297-2027
6Oct2026
Interventional Fluoroscopic X-Ray System
Reason: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduce…
Z-0298-2027