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Halifax Imaging Kit

Halifax Biomedical Incorporated · Model 1 · UDI-DI 00628451892021

MQB LLZ KPR Prescription

510(k) clearances

1,277

Adverse events (11 deaths)

195

Recalls

127

Facilities

Description

The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path to creating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing DR system are synchronized by replacing the trigger switches of the two systems with the Halifax Synchronization Switch. The Halifax Synchronization Switch ensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray images from two different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR). RSA is a stereo x-ray technique that enables measurements more accurate and precise than single plane radiography based on phantom studies. The increased level of precision enables measurement of implant stability.

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.