Signal · Regulation & Trade

ARCHITECT "I" System - i2000SR Processing Module - Class 4

Health Canada - Medical Device Alerts and Recalls (RSS) Authoritative source Published 16th October 2026 Canada

Open original report recalls-rappels.canada.ca

What the source reported

Source-reported

An issue has been identified with the 5 Amp (5A) diode used in the Induction Heater (IH) Control Module on the ARCHITECT i2000SR IH Kit (optional hardware). The diode may be exposed to current exceeding its specified rating, potentially resulting in component failure. Failure could cause localized electrical arcing, circuit board damage, and smoke generation. Only ARCHITECT i2000SR Processing Modules with an Induction Heater (IH) Control Module are impacted. The IH Control Module housing is classified as a fire enclosure in accordance with International Electrotechnical Commission (IEC) 61010-1 and is designed to contain thermal events. Protective features include flame-retardant circuit board material and a metal fire-rated enclosure, which help prevent propagation beyond the module. In all failures, the observed damage remained contained within the IH Control Module, and no injuries or property damage have been reported. There is potential for operator injury and property damage due to smoke, burn, hot surfaces, etc. caused by the excess current on the diode. There have been no occurrences of fire and smoke leading to property damage and no reported occurrences of operator injury for this issue.

Publication: Health Canada - Medical Device Alerts and Recalls (RSS) · Government/Regulator
Published: 16th October 2026
Original report: recalls-rappels.canada.ca

ProcIntel stores what the source published in its feed — a headline, a summary and a link. It does not store or reproduce the full article.

What ProcIntel recorded

ProcIntel-derived

Category: Regulation & Trade
Geography: Canada
Organisations: None identified
Collected: 16th October 2026 · 17:46

Initial assessment ProcIntel's automatic, provisional read of this individual Signal -- Initial Significance and Initial Confidence, computed deterministically before any Event extraction or human review.

A provisional, automatically computed reading of this individual Signal, before Event extraction or human review. Not a final rating.

Significance 1 · Low

Confidence 2 · Low

Initial Significance Low (11.0/100). Strongest contributor: Procurement Impact (6.0/30 points). Limiting factor: Geographic Breadth (0.0/10 points). Initial Confidence Low (35.5/100, data sufficiency: Insufficient). Strongest contributor: Source Authority (40.0/40 points). Limiting factor: Specificity (0.0/20 points).

Strongest contributor: Procurement Impact
Limiting factor: Geographic Breadth

What the source reported

What ProcIntel recorded

Initial assessment ⓘMore about Initial Signal AssessmentProcIntel's automatic, provisional read of this individual Signal -- Initial Significance and Initial Confidence, computed deterministically before any Event extraction or human review.

Initial assessment ProcIntel's automatic, provisional read of this individual Signal -- Initial Significance and Initial Confidence, computed deterministically before any Event extraction or human review.