Public recall detail

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

2026-10-16

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Health products Health product recall
Quick summary

Quick summary: ARCHITECT "I" System - i2000SR Processing Module - Class 4. Reason: Health product recall. Category: Health products. Date: 2026-10-16.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: ARCHITECT "I" System - i2000SR Processing Module - Class 4. Reason: Health product recall. Category: Health products. Date: 2026-10-16.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAbbott Laboratories
ProductARCHITECT "I" System - i2000SR Processing Module - Class 4
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82800

Affected products

ProductARCHITECT "I" System - i2000SR Processing Module - Class 4
LotISR64041
Model03M74-02
Serial numberISR64041
DescriptionARCHITECT "I" System - i2000SR Processing Module - Class 4

Issue

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesAbbott Laboratories 1915 Hurd Drive, Irving, Texas, United States, 75038
Recall date2026-10-07
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82800
Background{}
CompaniesAbbott Laboratories 1915 Hurd Drive, Irving, Texas, United States, 75038
AudiencesHealthcare
Source updated2026-10-16

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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