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Hologic recalls Horizon W/WI imaging systems over unapproved VGA cables in monitor replacements

🇨🇦 Health Canada · Thu 05 Nov 2026

Health Canada lists a Type II recall after replacement monitors shipped without the required VGA cable, so engineers may have fitted cables of unknown origin.

Health Canada has published a Type II recall for Hologic's Horizon Medical Imaging System, covering the Horizon W and Horizon WI models. The notice, last updated on 5 November 2026, gives a recall date of 28 September 2026 and the identification number RA-82912.

According to the notice, certain replacement monitors for Horizon W/WI systems released into production from January 2025 were shipped without the VGA cable needed to connect the monitor to the computer. Field service engineers may therefore have installed the systems using VGA cables of unknown origin.

This created a nonconformance linked to the use of unapproved components. The notice describes a potential risk of increased electromagnetic interference (EMI) emissions from VGA cables that Hologic has not evaluated or approved. It does not report any injuries or incidents.

The affected products are listed under the numbers 309700M, 309701M and 309702M, for both the HORIZON W and HORIZON WI models. The recall is categorised under radiology medical devices, with the issue type given as device compatibility. The audience is healthcare, and the notice tells users to contact the manufacturer if they need more information. Hologic is listed at 600 Technology Drive, Newark, Delaware.

For context, Health Canada uses a Type II classification where use of or exposure to a product may cause temporary or medically reversible adverse effects, or where the probability of serious harm is remote.

What it means for your team

  • Quality teams at device makers should check that replacement-part kits include every approved component, such as cables, and that field engineers do not substitute unapproved parts.
  • Healthcare facilities with Horizon W/WI systems may wish to review installation records for monitor replacements since January 2025 and contact Hologic for further information, as the notice advises.
  • Regulatory affairs teams may wish to note the EMI angle: unevaluated accessories can undermine a device's assessed electromagnetic emissions profile.
  • The notice gives no corrective action details beyond contacting the manufacturer, so teams should seek specifics directly from Hologic.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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