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HAD1717MC

H&abyz Co., Ltd · Model HAD1717MC · UDI-DI 08800070400012

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510(k) clearances

1,277

Adverse events (11 deaths)

195

Recalls

127

Facilities

Description

The HAD1717MC is a wired digital flat panel X-ray detector. The HAD1717MC X-ray detector consists of a TFT panel and a scintillator electronic controller, and supports AED (Automatic Exposure Detection) function that can operate without a separate trigger signal. Flat panel sensors for HAD1717MC are fabricated using thin film technology based on amorphous silicon technology, and the sensors are similar to existing photodiode arrays. In this case, each pixel is composed of a photodiode and a thin film transistor (TFT). Amorphous silicon photodiodes are optimized for green wavelengths and can be used in combination with scintillators such as CsI. The incident X-rays are converted into visible light by the scintillator, and the visible light is stored in an internal capacitor through a photodiode. Charges charged to capacitors switch TFT gates of panel matrix (panel matrix) and convert them into digital signals on a line and pass them to the control unit. The digital data generated is then passed to the PC via Ethernet.

Recalls

Date	Firm	Reason
2026-05-01	Philips North America Llc	System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
2025-10-01	Philips Medical Systems DMC GmbH	Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/ph
2023-05-19	Philips North America Llc	There is a software login in issue that may prevent the user from logging in.
2021-09-22	Philips Healthcare	The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation W
2021-03-11	LIEBEL-FLARSHEIM COMPANY LLC	Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual valu
2021-02-05	Canon Medical System, USA, INC.	The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
2020-12-08	Canon Medical System, USA, INC.	System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
2020-04-06	Siemens Medical Solutions USA, Inc	It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will
2020-03-03	Canon Medical System, USA, INC.	Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
2020-01-07	Palodex Group Oy	Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and

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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.