Health Canada lists Type II recall of Hologic Horizon systems over missing monitor cable

A gap in how replacement parts were packed has landed Hologic with a recall in Canada. Health Canada's notice, last updated on 5 November 2026, covers the Horizon Medical Imaging System in its W and WI versions. It carries the identification number RA-82912 and a recall date of 28 September 2026. The notice does not say how many units are affected, what the recall will cost, or whether other markets are involved.

The problem lies in the service channel rather than in the imaging hardware itself. Replacement monitors for the two models, released into production from January 2025, were shipped without the VGA cable that links the screen to the computer. Field service engineers may therefore have completed installations with cables Hologic had not sourced, and the notice says their origin is unknown.

The regulator's concern is electromagnetic. Cables that were never evaluated or approved for the system could raise its electromagnetic emissions. The notice reports no injuries or incidents. Health Canada files the recall under radiology devices, with the issue labelled as one of compatibility. The affected product numbers are 309700M, 309701M and 309702M, across both models.

For context, Health Canada applies a Type II classification where use of or exposure to a product may cause temporary or medically reversible adverse effects, or where the chance of serious harm is remote. The notice's only instruction is for users to contact the manufacturer, which is listed at 600 Technology Drive, Newark, Delaware. It sets out no corrective steps, so the practical remedy is not yet public.