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RecallTech & trendsCanada

Boston Scientific updates flushing and preparation instructions for OptiCross imaging catheters

Boston Scientific issued an advisory for the OptiCross family of intravascular ultrasound imaging catheters. The manufacturer is updating flushing instructions and reinforcing device preparation and air-management practices. Users should consult the updated Instructions for Use for the specific products listed in the company's customer letter.

If you use these catheters, review the updated flushing and air-management protocols to ensure proper device preparation before use.

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Official source: Boston Scientific updates flushing and preparation instructions for OptiCross imaging catheters (opens in a new tab) — Health Canada recalls and alerts

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OpinionTech & trendsCanada

Governance requirements remain for digital health tools built using AI

Health organizations using AI to accelerate digital tool development must still complete standard privacy, security, and procurement reviews. While AI can speed up coding, it does not automate the necessary governance documentation. Custodians remain accountable for personal health information regardless of the development method used.

Before adopting AI-built tools, confirm with vendors that they use enterprise agreements with zero data retention and only synthetic data in development environments.

News source: Digital Health Canada (opens in a new tab)

RecallTech & trendsCanada

QuidelOrtho reports potential for biased results in Vitros A1c slides

QuidelOrtho has identified an issue where certain generations of Vitros chemistry products A1c slides may produce positively biased results. The manufacturer has received 58 complaints regarding this performance issue as of October 15, 2026. No adverse events have been reported to date.

If you use these slides in your lab, contact the manufacturer for further guidance on managing potential result inaccuracies.

Official source: Health Canada recalls and alerts (opens in a new tab)

RecallTech & trendsInternational

Philips Azurion imaging systems face potential power failure and functionality loss

Philips identified a safety issue where power supply units in certain Azurion systems may fail during startup or restart. Energy surges can cause these components to malfunction, preventing the system from completing its boot process. This failure renders the imaging equipment unavailable for clinical use.

If you operate this equipment, contact the manufacturer for further guidance on managing potential startup failures.

Official source: Health Canada recalls and alerts (opens in a new tab)

RecallTech & trendsCanada

RotaFlow console battery charging failure identified by manufacturer

The manufacturer identified a software issue affecting all RotaFlow consoles on the market. This fault can prevent the device from charging its battery after the unit has operated in battery mode. Users should contact the manufacturer for further information regarding this device defect.

If you use RotaFlow consoles in your clinical practice, contact the manufacturer to determine how this charging issue affects your equipment's reliability.

Official source: Health Canada recalls and alerts (opens in a new tab)