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

Companies: Abbott Laboratories, 1915 Hurd Drive, Irving, Texas, United States, 75038.

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.